52 Clinical Research jobs in Kuala Lumpur

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.

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.

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.

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.

Fortrea Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

Join to apply for the Clinical Research Associate II role at 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 role at 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.
  
  

• 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.
  
  

• 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.
  
  

• 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.
  
  

• 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.
  
  

• 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).
  
  

• Seniority level Entry level

• Employment type Full-time

• Job function Research, Analyst, and Information Technology

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PSI CRO is a dynamic, global company founded in 1995, bringing 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.

We are seeking a knowledgeable, team-oriented Senior Clinical Research Associate to manage the clinical aspects of full-service global projects 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 will maintain the highest quality standards in the industry, while performing and supervising study start-up, clinical monitoring and site management activities on the country/regional level. You will become one of our first team members in Malaysia and contribute to the development of PSI Operations.

• 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.

• 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.

PSI is an equal opportunities employer and welcomes applications from all qualified candidates.

Overview

Position Title/Designation: Sr Clinical Research Associate (CRA)

Location: Malaysia

Experience Required: 3–4 years of CRA experience

• Manage assigned clinical studies, support sites with EC approvals, training.
• End to End site Management
• Ensure compliance with SOPs, GCP & regulatory requirements.
• Act as main point of contact for sites, ensuring smooth study conduct, accurate data & SAE reporting.
• Coordinate with internal teams, labs & vendors; track invoices & study supplies as applicable

Ready to explore new opportunities! Write to us at:

Job Overview
The Senior CRA I is responsible for site monitoring and site management. Responsibility for clinical studies according to Fortrea, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. The Senior CRA I assure the implementation of project plans, as assigned. Function as leader for projects of limited scope, as assigned. Assume line management responsibilities, as assigned. Act in the project role of a Local Project Coordinator or Lead CRA as assigned.

Summary Of Responsibilities

• Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.
• Responsible for all aspects of site management as prescribed in the project plans.

Qualifications (Minimum Required)

• University or college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.
• In lieu of the above education requirement, candidates with a minimum of 3 years relevant clinical research experience in pharmaceutical or CRO industries will be considered.
• Thorough knowledge of regulatory requirements including a basic understanding of regulatory requirements in other countries.
• Thorough understanding of the drug development 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)

• Typically Three (3) years of clinical onsite monitoring experience.
• Have a full understanding of Serious Adverse Event (SAE) reporting, process production on reports, narratives and follow up of SAEs.
• Advanced site monitoring skills.
• Advanced study site management skills.
• Advanced registry administration skills.
• Ability to work with minimal supervision.
• Valid Driver's License.

Physical Demands/Work Environment

• Travel requirements: 60-80%

Learn more about our EEO & Accommodations request here.