23 Clinical Research jobs in Kuala Lumpur

Tigermed Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

Clinical Research Associate

Tigermed Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

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1.1 This position is responsible for project management and study site management from site selection to initiation until monitoring and close-out of assigned clinical study studies in accordance with Tigermed or sponsor Standard Operating Procedures (SOPs), International Conference on Harmonization Good Clinical Practice standard (ICH-GCP), Clinical Practice standard (GCP) and other applicable regulations.

1.2 The position is responsible for ensuring that all data generated by the assigned sites is of high quality, on time and within budget.

2.Responsibilities

(a) Site management

•Study site selection, initiation (SIV) and clinical monitoring.

•Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience.

•Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations.

•Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP.

•Track study recruitment to ensure recruitment target is achieved in all studies.

•Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating.

•Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study.

•Assemble site specific EC submission dossier, and ensure submission to EC.

Training

•Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements.

•Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements.

Documentation

•Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files.

•Prepare/complete study records’ archiving according to protocol and sponsor requirements.

(b) Drug Safety

•Ensure safety information is disseminated to all sites according SOP and applicable regulations.

•Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations.

(c) Finance and Administration

•Finalize budget and obtain signed contract from site, prior to site initiation visit.

•Ensure Study Payment Schedule is executed and retain relevant documents/receipts.

(d) Study Tools and system

•Update and maintain Study tools/systems in a timely manner.

3. Qualifications

3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. The excellent candidates will not be restricted to the current requirements;

3.2 At least 1 year of CRA experience;

3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures;

3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.

Seniority level

• Seniority level Associate

Employment type

• Employment type Full-time

Job function

• Job function Research
• Industries Pharmaceutical Manufacturing

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Tigermed Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia Clinical Research Associate

Tigermed Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Tigermed 1.1 This position is responsible for project management and study site management from site selection to initiation until monitoring and close-out of assigned clinical study studies in accordance with Tigermed or sponsor Standard Operating Procedures (SOPs), International Conference on Harmonization Good Clinical Practice standard (ICH-GCP), Clinical Practice standard (GCP) and other applicable regulations. 1.2 The position is responsible for ensuring that all data generated by the assigned sites is of high quality, on time and within budget. 2.Responsibilities (a) Site management •Study site selection, initiation (SIV) and clinical monitoring. •Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience. •Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations. •Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP. •Track study recruitment to ensure recruitment target is achieved in all studies. •Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating. •Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study. •Assemble site specific EC submission dossier, and ensure submission to EC. Training •Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements. •Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements. Documentation •Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files. •Prepare/complete study records’ archiving according to protocol and sponsor requirements. (b) Drug Safety •Ensure safety information is disseminated to all sites according SOP and applicable regulations. •Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations. (c) Finance and Administration •Finalize budget and obtain signed contract from site, prior to site initiation visit. •Ensure Study Payment Schedule is executed and retain relevant documents/receipts. (d) Study Tools and system •Update and maintain Study tools/systems in a timely manner. 3. Qualifications 3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. The excellent candidates will not be restricted to the current requirements; 3.2 At least 1 year of CRA experience; 3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures; 3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc. Seniority level

Seniority level Associate Employment type

Employment type Full-time Job function

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Tigermed Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

Clinical Research Associate (MJ0009)

Tigermed Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

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Direct message the job poster from Tigermed

1.1 This position is responsible for project management and study site management from site selection to initiation until monitoring and close-out of assigned clinical study studies in accordance with Tigermed or sponsor Standard Operating Procedures (SOPs), International Conference on Harmonization Good Clinical Practice standard (ICH-GCP), Clinical Practice standard (GCP) and other applicable regulations.

1.2 The position is responsible for ensuring that all data generated by the assigned sites is of high quality, on time and within budget.

2.Responsibilities

(a) Site management

•Study site selection, initiation (SIV) and clinical monitoring.

•Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience.

•Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations.

•Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP.

•Track study recruitment to ensure recruitment target is achieved in all studies.

•Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating.

•Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study.

•Assemble site specific EC submission dossier, and ensure submission to EC.

Training

•Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements.

•Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements.

Documentation

•Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files.

•Prepare/complete study records’ archiving according to protocol and sponsor requirements.

(b) Drug Safety

•Ensure safety information is disseminated to all sites according SOP and applicable regulations.

•Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations.

(c) Finance and Administration

•Finalize budget and obtain signed contract from site, prior to site initiation visit.

•Ensure Study Payment Schedule is executed and retain relevant documents/receipts.

(d) Study Tools and system

•Update and maintain Study tools/systems in a timely manner.

3. Qualifications

3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. The excellent candidates will not be restricted to the current requirements;

3.2 At least 1 year of CRA experience;

3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures;

3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.

Seniority level

• Seniority level Associate

Employment type

• Employment type Full-time

Job function

• Job function Research
• Industries Pharmaceutical Manufacturing

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Federal Territory of Kuala Lumpur, Malaysia 6 days ago

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Petaling Jaya, Selangor, Malaysia 4 days ago

Research Assistant/Analyst/Associate, Global Credit - Ratings and Monitoring

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 5 days ago

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Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 4 months ago

Rep II - Customer Service Shared Services

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 2 months ago

Project Manager (Clinical Trial Support)

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 2 weeks ago

Petaling Jaya, Selangor, Malaysia 5 days ago

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Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together 3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

PSI’s business is about conducting clinical research of novel medications. We work at the interface of R&D, pharmaceutical industry and healthcare science and provide services to big and mid-sized pharmaceutical companies. We help our clients to generate data about safety and efficacy of medications and bring the best ones to market. By conducting global clinical research trials, PSI makes cutting-edge treatment available in drugstores all over the world and helps patients with serious medical conditions to improve or even save their life. Help us to make sure that PSI medical and business documents are clear to patients, physicians, regulatory authorities, and clients.

We offer an inspiring story of the company that has grown organically from a handful of countries to global presence. PSI is a mature company with standards and practices, but we do not stand still. Every day, there is a figurative Everest to climb, and you will not get bored here.

Job Description

We’re searching for a knowledgeable, team-oriented Senior CRA to manage the clinical aspects of full-service globalprojects in Malaysia. As a Senior CRA at PSI, you will work on the frontline of communication with project stakeholders, ensuring the successful conduct of clinical trials in a variety of therapeutic indications. You willmaintain the highest quality standards in the industry, whileperforming and supervisingstudy start-up, clinical monitoring and site management activities on the country/regionallevel.

You will become one of our first team members in Malaysia and contribute to the development of PSI Operations. The candidate can be based anywhere in Malaysia.

You will:

• Supervise study activities, timelines, milestones, and schedules on the country level.
• Conduct and report all types of onsite monitoring visits.
• Be involved in study set-up, including site contract and budget negotiations.
• Be responsible for site communication and management.
• Ensure consistency of all study processes and identify country differences.
• Oversee maintenance of study-specific and corporate tracking systems.
• Contribute to the development and update of project planning documents, essential documents, and project instructions.
• Be a point of contact for in-house support services, contractors, global cross-functional teams, and vendors.
• Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.
• Development of local language materials including local language Informed Consents and translations.
• Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.

Qualifications

The ideal candidate must possess the following qualifications:

• Bachelor's degree in Life Sciences, Pharmacy, or Registered Nursing; or an equivalent combination of education, training, and experience. Registered pharmacists are strongly preferred.
• Minimum of 4-5 years of demonstrable, independent on-site monitoring experience or equivalent expertise.
• Extensive experience in conducting all types of monitoring visits in Phase II and/or III clinical trials.
• Proficiency in feasibility assessment and study set-up processes is highly desirable.
• Specialized experience in Oncology or Hematology therapeutic indications is a significant advantage.
• Demonstrated ability to plan effectively, multitask efficiently, and thrive in a dynamic team environment.
• Superior communication, collaboration, and problem-solving skills are essential.
• Willingness and ability to travel extensively within Malaysia is a prerequisite for this position.

Additional Information

How are we different?

PSI is privately owned by the very people who founded the company more than 25 years ago, and they’re still working here today. As a result, we have grown organically around the globe and have kept our company fully independent, giving us significant advantages and freedoms.

Growth Opportunities

PSI is proud to invest in our people, from entry-level team members to senior leaders, helping you identify and hone your unique strengths at every step of your career. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career.

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Novotech Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

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Novotech Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

2 days ago Be among the first 25 applicants

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Brief Position Description:
The Clinical Research Associate (CRA) is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from the source documents. The CRA is the primary contact between the Investigational Sites, Novotech, and Sponsor. Key responsibility of a CRA is as a site relationship manager ensuring that clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs.

Minimum Qualifications & Experience:

• At least 1 year of independent clinical monitoring experience
• Graduate in a clinical or life sciences-related field. Relevant experience/qualifications in allied professions may also be considered.
• Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate.
• Preferably experience of working in the research, pharmaceutical industry or a related field per job level as follows:
  
  
  • CRA II: Approximately 1-2 years of Clinical Research Associate experience or equivalent experience (CRA II fast track) in other roles in the Clinical industry.
  • CRA III: At least 2-3 years of Clinical Research Associate experience in the Clinical industry.
  • Senior CRA (SCRA): At least 3-5 years of Clinical Research Associate experience in the Clinical industry.
  • Principal CRA (PCRA): At least 5 years of Clinical Research Associate experience in the Clinical industry.

Responsibilities:

• CRAs primary responsibility is to build relationships with Principal Investigators, study coordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited, and smooth management of clinical trials.
• In collaboration with IHCRA or DMA team, ensure the project Trial Master File (TMF) is up to date, current and complete always throughout duration of the study.
• Monitoring of investigational sites as per ICH GCP §5.18 (Monitoring) and the Clinical Monitoring Plan (CMP) for each study. This includes all monitoring visit types across all phases of a clinical trial including Site Selection, Site Initiation, Site Monitoring and Site Close Out, unblinded pharmacy visits, and co-monitoring visits. Visits can be conducted either onsite or remote as per CMP.
• Responsible for learning the company culture, policies, and procedures through specialized training called CRA II fast track training program including observational visits for all types of visits (if applicable) and on the job training by supporting the day-to-day CRA activities of clinical project team members such as CRAs and Line managers (LMs).
• Provide written and verbal site updates (including monitoring visit reports) on study progress to the PM/LCRA according to the study requirements/timelines as documented in the Clinical Monitoring Plan and Sponsor/Novotech SOPs. Escalate all key issues as per Issue Escalation SOP.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.

Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.

Seniority level

• Seniority level Mid-Senior level

Employment type

• Employment type Full-time

Job function

• Job function Research and Science

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Trial Capabilities Senior Associate For Asia Pacific Region Research Assistant/Analyst/Associate, Global Credit - Ratings and Monitoring Rep II - Customer Service Shared Services

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 1 month ago

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Fortrea Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

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Fortrea Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

4 days ago Be among the first 25 applicants

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• Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records.
• Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.
• Prepares and implements project plans related to Clinical Monitoring responsibilities.
• Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.
• Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.
• Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.
• Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements.
• Ensures adherence to global quality control and CRA performance metrics.
• Ensures audit readiness at site level.
• Acts in the project role of a Lead CRA as assigned.
• General On-Site Monitoring Responsibilities:
• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study. Ensure the protection of study subjects or patients by performing eligibility review, verifying that screening, informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
• Ensure the integrity of the source data reported by careful source document review. Monitor data for missing or implausible data.
• Ensure study data completeness, accuracy, consistency, and compliance; identify deficiencies, deviations and discrepancies, and initiate corrective action as required.
• Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.
• Travel, including air travel, may be required and is an essential function of the job.
• Prepare and submit accurate and timely trip reports.
• Independently perform eCRF review, 100% source data verification, query generation and resolution against established data review guideline with or without direct supervision, on Fortrea or client data management systems, as assigned by management.
• Assist with the administration of clinical research projects, recruiting investigators (if applicable), collecting investigator documentation and site management.
• Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems.
• Track IP shipments and supplies, as needed.
• Track and follow-up on serious adverse events as assigned.
• Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met.
• Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned.
• Attend investigators’ meetings (if applicable), project team meetings and teleconferences, and others as needed.
• Present training content for site initiation.
• Assist with training of new employees (e.g., co-monitoring).
• All other duties as needed or assigned.
  
  

Summary Of Responsibilities

• Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records.
• Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.
• Prepares and implements project plans related to Clinical Monitoring responsibilities.
• Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.
• Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.
• Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.
• Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements.
• Ensures adherence to global quality control and CRA performance metrics.
• Ensures audit readiness at site level.
• Acts in the project role of a Lead CRA as assigned.
• General On-Site Monitoring Responsibilities:
• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study. Ensure the protection of study subjects or patients by performing eligibility review, verifying that screening, informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
• Ensure the integrity of the source data reported by careful source document review. Monitor data for missing or implausible data.
• Ensure study data completeness, accuracy, consistency, and compliance; identify deficiencies, deviations and discrepancies, and initiate corrective action as required.
• Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.
• Travel, including air travel, may be required and is an essential function of the job.
• Prepare and submit accurate and timely trip reports.
• Independently perform eCRF review, 100% source data verification, query generation and resolution against established data review guideline with or without direct supervision, on Fortrea or client data management systems, as assigned by management.
• Assist with the administration of clinical research projects, recruiting investigators (if applicable), collecting investigator documentation and site management.
• Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems.
• Track IP shipments and supplies, as needed.
• Track and follow-up on serious adverse events as assigned.
• Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met.
• Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned.
• Attend investigators’ meetings (if applicable), project team meetings and teleconferences, and others as needed.
• Present training content for site initiation.
• Assist with training of new employees (e.g., co-monitoring).
• All other duties as needed or assigned.
  
  

Qualifications (Minimum Required)

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
• Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.
• Thorough knowledge of monitoring procedures.
• Basic understanding of the clinical trial process.
• Fluent in local office language and in English, both written and verbal.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
  
  

Experience (Minimum Required)

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). AND
• A minimum of 2 years of Clinical Monitoring experience.
  
  

Preferred Qualifications Include

• Thorough working knowledge of Fortrea SOPs for site monitoring.
• One (1) or more additional years of experience in a related field (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
• Phase I monitoring experience.
• Life Science or Nursing qualification.
• Specific skills, systems, certifications, and/or licenses preferred.
• Personal characteristics (leadership, problem solving, interpersonal skills).
• Good attention to detail.
• Methodical approach to work.
• Good understanding of medical and clinical research terminology and clinical research processes.
• An understanding of the basics of physiology, pharmacology, and medical devices (when applicable).
• Good understanding of the principles of ICH GCP, ISO 14155 (if applicable) and local regulatory requirements.
• Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications.
• Good oral and written internal and external communication. Strong interpersonal team and organizational skills, personal presentation. The ability to communicate effectively in English.
• Focus on Customer.
• Innovate and Change.
• Pursue Scientific and Process Excellence.
• Work with Others.
• Achieve Results.
• Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors.
• Demonstrated ability to conduct clinical operations activities most effectively and efficiently.
• Good analytical and negotiation skills.
• Experience using e-clinical systems (e.g., clinical trial management system (CTMS)).
• For medical device positions, experience in providing customer service to device end users.
  
  

Physical Demands/Work Environment

• Must be able to sit at a computer for long periods of time.
• Must be able to use hands to finger, handle or touch objects, tools or controls, including a computer keyboard, for up to 8 hours per day.
• Standard office and/or home working environment.
• Clinical Research Unit and hospital environment (administrative only).
• Risk of eye strain.
• Will involve outside of normal office hours as required by the role.
• Travel Requirement is 60% of the time (traveling to study sites).
  
  

Learn more about our EEO & Accommodations request here.Seniority level

• Seniority level Entry level

Employment type

• Employment type Full-time

Job function

• Job function Research, Analyst, and Information Technology

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Get notified about new Clinical Research Associate jobs in Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia .

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Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together 3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. PSI’s business is about conducting clinical research of novel medications. We work at the interface of R&D, pharmaceutical industry and healthcare science and provide services to big and mid-sized pharmaceutical companies. We help our clients to generate data about safety and efficacy of medications and bring the best ones to market. By conducting global clinical research trials, PSI makes cutting-edge treatment available in drugstores all over the world and helps patients with serious medical conditions to improve or even save their life. Help us to make sure that PSI medical and business documents are clear to patients, physicians, regulatory authorities, and clients. We offer an inspiring story of the company that has grown organically from a handful of countries to global presence. PSI is a mature company with standards and practices, but we do not stand still. Every day, there is a figurative Everest to climb, and you will not get bored here. Job Description We’re searching for a knowledgeable, team-oriented Senior CRA to manage the clinical aspects of full-service globalprojects in Malaysia. As a Senior CRA at PSI, you will work on the frontline of communication with project stakeholders, ensuring the successful conduct of clinical trials in a variety of therapeutic indications. You willmaintain the highest quality standards in the industry, whileperforming and supervisingstudy start-up, clinical monitoring and site management activities on the country/regionallevel. You will become one of our first team members in Malaysia and contribute to the development of PSI Operations. The candidate can be based anywhere in Malaysia. You will: Supervise study activities, timelines, milestones, and schedules on the country level. Conduct and report all types of onsite monitoring visits. Be involved in study set-up, including site contract and budget negotiations. Be responsible for site communication and management. Ensure consistency of all study processes and identify country differences. Oversee maintenance of study-specific and corporate tracking systems. Contribute to the development and update of project planning documents, essential documents, and project instructions. Be a point of contact for in-house support services, contractors, global cross-functional teams, and vendors. Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols. Development of local language materials including local language Informed Consents and translations. Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols. Qualifications The ideal candidate must possess the following qualifications: Bachelor's degree in Life Sciences, Pharmacy, or Registered Nursing; or an equivalent combination of education, training, and experience. Registered pharmacists are strongly preferred. Minimum of 4-5 years of demonstrable, independent on-site monitoring experience or equivalent expertise. Extensive experience in conducting all types of monitoring visits in Phase II and/or III clinical trials. Proficiency in feasibility assessment and study set-up processes is highly desirable. Specialized experience in Oncology or Hematology therapeutic indications is a significant advantage. Demonstrated ability to plan effectively, multitask efficiently, and thrive in a dynamic team environment. Superior communication, collaboration, and problem-solving skills are essential. Willingness and ability to travel extensively within Malaysia is a prerequisite for this position. Additional Information

How are we different? PSI is privately owned by the very people who founded the company more than 25 years ago, and they’re still working here today. As a result, we have grown organically around the globe and have kept our company fully independent, giving us significant advantages and freedoms. Growth Opportunities PSI is proud to invest in our people, from entry-level team members to senior leaders, helping you identify and hone your unique strengths at every step of your career. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career.

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Fortrea Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia Join or sign in to find your next job

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Clinical Research Associate II

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Fortrea Fortrea Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 4 days ago Be among the first 25 applicants Join to apply for the

Clinical Research Associate II

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Fortrea Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records. Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits. Prepares and implements project plans related to Clinical Monitoring responsibilities. Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements. Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems. Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial. Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements. Ensures adherence to global quality control and CRA performance metrics. Ensures audit readiness at site level. Acts in the project role of a Lead CRA as assigned. General On-Site Monitoring Responsibilities: Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study. Ensure the protection of study subjects or patients by performing eligibility review, verifying that screening, informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. Ensure the integrity of the source data reported by careful source document review. Monitor data for missing or implausible data. Ensure study data completeness, accuracy, consistency, and compliance; identify deficiencies, deviations and discrepancies, and initiate corrective action as required. Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy. Travel, including air travel, may be required and is an essential function of the job. Prepare and submit accurate and timely trip reports. Independently perform eCRF review, 100% source data verification, query generation and resolution against established data review guideline with or without direct supervision, on Fortrea or client data management systems, as assigned by management. Assist with the administration of clinical research projects, recruiting investigators (if applicable), collecting investigator documentation and site management. Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems. Track IP shipments and supplies, as needed. Track and follow-up on serious adverse events as assigned. Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met. Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned. Attend investigators’ meetings (if applicable), project team meetings and teleconferences, and others as needed. Present training content for site initiation. Assist with training of new employees (e.g., co-monitoring). All other duties as needed or assigned.

Summary Of Responsibilities

Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records. Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits. Prepares and implements project plans related to Clinical Monitoring responsibilities. Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements. Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems. Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial. Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements. Ensures adherence to global quality control and CRA performance metrics. Ensures audit readiness at site level. Acts in the project role of a Lead CRA as assigned. General On-Site Monitoring Responsibilities: Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study. Ensure the protection of study subjects or patients by performing eligibility review, verifying that screening, informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. Ensure the integrity of the source data reported by careful source document review. Monitor data for missing or implausible data. Ensure study data completeness, accuracy, consistency, and compliance; identify deficiencies, deviations and discrepancies, and initiate corrective action as required. Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy. Travel, including air travel, may be required and is an essential function of the job. Prepare and submit accurate and timely trip reports. Independently perform eCRF review, 100% source data verification, query generation and resolution against established data review guideline with or without direct supervision, on Fortrea or client data management systems, as assigned by management. Assist with the administration of clinical research projects, recruiting investigators (if applicable), collecting investigator documentation and site management. Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems. Track IP shipments and supplies, as needed. Track and follow-up on serious adverse events as assigned. Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met. Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned. Attend investigators’ meetings (if applicable), project team meetings and teleconferences, and others as needed. Present training content for site initiation. Assist with training of new employees (e.g., co-monitoring). All other duties as needed or assigned.

Qualifications (Minimum Required)

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate. Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements. Thorough knowledge of monitoring procedures. Basic understanding of the clinical trial process. Fluent in local office language and in English, both written and verbal. Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required)

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). AND A minimum of 2 years of Clinical Monitoring experience.

Preferred Qualifications Include

Thorough working knowledge of Fortrea SOPs for site monitoring. One (1) or more additional years of experience in a related field (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred. Phase I monitoring experience. Life Science or Nursing qualification. Specific skills, systems, certifications, and/or licenses preferred. Personal characteristics (leadership, problem solving, interpersonal skills). Good attention to detail. Methodical approach to work. Good understanding of medical and clinical research terminology and clinical research processes. An understanding of the basics of physiology, pharmacology, and medical devices (when applicable). Good understanding of the principles of ICH GCP, ISO 14155 (if applicable) and local regulatory requirements. Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications. Good oral and written internal and external communication. Strong interpersonal team and organizational skills, personal presentation. The ability to communicate effectively in English. Focus on Customer. Innovate and Change. Pursue Scientific and Process Excellence. Work with Others. Achieve Results. Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors. Demonstrated ability to conduct clinical operations activities most effectively and efficiently. Good analytical and negotiation skills. Experience using e-clinical systems (e.g., clinical trial management system (CTMS)). For medical device positions, experience in providing customer service to device end users.

Physical Demands/Work Environment

Must be able to sit at a computer for long periods of time. Must be able to use hands to finger, handle or touch objects, tools or controls, including a computer keyboard, for up to 8 hours per day. Standard office and/or home working environment. Clinical Research Unit and hospital environment (administrative only). Risk of eye strain. Will involve outside of normal office hours as required by the role. Travel Requirement is 60% of the time (traveling to study sites).

Learn more about our EEO & Accommodations request here. Seniority level

Seniority level Entry level Employment type

Employment type Full-time Job function

Job function Research, Analyst, and Information Technology Referrals increase your chances of interviewing at Fortrea by 2x Get notified about new Clinical Research Associate jobs in

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Novotech Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia Join or sign in to find your next job

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Clinical Research Associate FSP

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Novotech Novotech Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 2 days ago Be among the first 25 applicants Join to apply for the

Clinical Research Associate FSP

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Novotech Get AI-powered advice on this job and more exclusive features. Brief Position Description: The Clinical Research Associate (CRA) is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from the source documents. The CRA is the primary contact between the Investigational Sites, Novotech, and Sponsor. Key responsibility of a CRA is as a site relationship manager ensuring that clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs.

Minimum Qualifications & Experience: At least 1 year of independent clinical monitoring experience Graduate in a clinical or life sciences-related field. Relevant experience/qualifications in allied professions may also be considered. Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate. Preferably experience of working in the research, pharmaceutical industry or a related field per job level as follows:

CRA II: Approximately 1-2 years of Clinical Research Associate experience or equivalent experience (CRA II fast track) in other roles in the Clinical industry. CRA III: At least 2-3 years of Clinical Research Associate experience in the Clinical industry. Senior CRA (SCRA): At least 3-5 years of Clinical Research Associate experience in the Clinical industry. Principal CRA (PCRA): At least 5 years of Clinical Research Associate experience in the Clinical industry.

Responsibilities: CRAs primary responsibility is to build relationships with Principal Investigators, study coordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited, and smooth management of clinical trials. In collaboration with IHCRA or DMA team, ensure the project Trial Master File (TMF) is up to date, current and complete always throughout duration of the study. Monitoring of investigational sites as per ICH GCP §5.18 (Monitoring) and the Clinical Monitoring Plan (CMP) for each study. This includes all monitoring visit types across all phases of a clinical trial including Site Selection, Site Initiation, Site Monitoring and Site Close Out, unblinded pharmacy visits, and co-monitoring visits. Visits can be conducted either onsite or remote as per CMP. Responsible for learning the company culture, policies, and procedures through specialized training called CRA II fast track training program including observational visits for all types of visits (if applicable) and on the job training by supporting the day-to-day CRA activities of clinical project team members such as CRAs and Line managers (LMs). Provide written and verbal site updates (including monitoring visit reports) on study progress to the PM/LCRA according to the study requirements/timelines as documented in the Clinical Monitoring Plan and Sponsor/Novotech SOPs. Escalate all key issues as per Issue Escalation SOP. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Seniority level

Seniority level Mid-Senior level Employment type

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Job function Research and Science Referrals increase your chances of interviewing at Novotech by 2x Sign in to set job alerts for “Clinical Research Associate” roles.

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