What Jobs are available for Study Coordinator in Malaysia?
Showing 19 Study Coordinator jobs in Malaysia
Regional Study Coordinator
Posted 15 days ago
Job Viewed
Job Description
Are you interested in making a real scientific impact through your everyday work? Would you enjoy working in a team-focused environment as you explore unique career opportunities?
If you are looking for a company where you can personally advance healthcare and make a difference in peoples' lives with your bold ideas and unique point of view, consider working at Labcorp as a **Regional Study Coordinator** .
**In more details, you will**
+ Be responsible for managing clinical projects to ensure the successful delivery of all lab services, including kits shipment, sample testing and sample management of a clinical study for the Asia region
+ Act as regional liaison between Labcorp Central Lab Services (CLS) Global Study Manager and various CLS departments involved in the clinical protocol
+ Close collaboration with the Global Study Manager for all study related aspects that are pertaining to the Asia platforms and through all study stages, from set-up to closure
+ Review the study Statement of Work, a document that specifies the scope of services CLS will perform for a clinical protocol and contains information approved by the sponsor and necessary to define the protocol specific database, to ensure regional feasibility and make appropriate recommendations to the Study Design Lead
+ Ensure a detailed knowledge of the Statement of Work specifications and very good understanding of how they impact every lab services aspect of the clinical trial
+ Manage day-to-day regional study related activities, including responding and resolving challenges in logistics, lab tests resulting, monitoring and study supplies, keeping the Global Study Manager informed of any study development
+ Monitor, track and provide resolution to all local study issues, keeping the Global Study Manager in the communication loop
+ Responsible for implementing monitoring and setting up of local performance metrics and taking corrective actions when needed.
+ Liaise with the Global Study Manager for any tasks assigned to the Regional Study Coordinator as part of the Global Monitoring Plan
+ Demonstrate ability to work in a matrix environment where task assignments can be channeled down to be completed by Regional Study Coordinators while other task assignments will need to be delegated to other functional groups; demonstrate flexibility in handling both categories of tasks
+ Participate in functional meetings, learning forum and provide input, keeping processes up to date
+ Support a culture of continuous improvement, quality and productivity
+ Support CLS Global Project Management strategy and deliver outstanding customer satisfaction and performance
**Thrive personally and professionally at Labcorp**
Working at Labcorp, you'll continue to grow in our learning-based culture so you'll know how to expertly respond and adapt as the industry continues to evolve. Here, you'll put your education to work as you play a meaningful role in advancing healthcare and making a difference in people's life.
In addition, Labcorp offers great benefits, global experience and the opportunity to work independently within a team-oriented environment.
**What we're looking for**
Regional Study Coordinators are the most successful at Labcorp with:
+ Bachelor Degree in relevant fields.
+ Relevant professional / internship experience in clinical research or pharmaceutical industry will be an advantage
+ Ability to use computer and office software applications (e.g. Microsoft Word, Excel, MS-Access and Outlook)
+ Strong interpersonal skills
+ Influence and negotiation skills
+ Demonstrated ability to plan and prioritize.
+ Demonstrated communication and organizational skills.
+ Demonstrated attention to detail.
+ Proven ability to excel in a fast paced environment
+ Proven teamwork
+ Proven experience and knowledge of processes and tools used in department
+ Demonstrated ability to liaise with internal departments
+ Demonstrated ability to facilitate meetings
+ Demonstrated participation in process improvement initiatives
+ Liaising with China counterparts is expected, proficiency of Chinese is essential
**Get to know Labcorp**
At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations.
Here, you can join our more than 60,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people's lives.
**Labcorp is proud to be an Equal Opportunity Employer:**
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
**We encourage all to apply**
If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site ( or contact us at Labcorp Accessibility. ( ) For more information about how we collect and store your personal data, please see our Privacy Statement ( .
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Study Coordinator (MeMoSA)
Posted 2 days ago
Job Viewed
Job Description
The ideal candidate for this position will be meticulous, organized, and proactive in carrying out the data collection protocol and be able to maintain a high level of accuracy with minimal supervision. An interest in digital health and knowledge of dentistry/oral cancer would be an advantage.
Major Duties and Responsibilities
Recruitment and follow‑up of patients for image collection into MeMoSA® AI project.
Capturing images of patients’ oral cavities via the MeMoSA® mobile application.
Data collection from clinical case notes, data entry and data analysis into the MeMoSA® database.
Ensure all documentation relating to the study is duly completed.
Assist in ethics applications to initiate any MeMoSA® AI related studies in clinical sites.
Systematic and routine reporting on progress of patient recruitment, data collection and analysis.
Assist MeMoSA® team members with data extraction, review and cleaning for the MeMoSA® AI project.
Able to work collaboratively with clinical counterparts and patients at clinical sites.
Undertake any other duties that may be assigned from time to time.
Qualifications and Competencies
Bachelor’s degree in any science‑based discipline with relevant transferrable skills.
Good team player, ability to communicate and work with all levels of stakeholders, able to multitask and work in a fast‑paced environment.
Excellent organizational and time management skills and ability to work under pressure.
Proven capability in hands‑on problem solving, with the ability to generate ideas and solutions; self‑motivated and results driven.
Pro‑active, meticulous, and maintain a high‑level accuracy with minimal supervision.
Willing to travel to clinical sites with own transport.
We are an independent and non‑profit cancer research organization based in Malaysia. Funded by donations and research grants, we conduct research in niche cancers often found in our Asian population.
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Regional Study Coordinator
Posted 16 days ago
Job Viewed
Job Description
Are you interested in making a real scientific impact through your everyday work? Would you enjoy working in a team-focused environment as you explore unique career opportunities?
If you are looking for a company where you can personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view, consider working at Labcorp as a
Regional Study Coordinator .
Responsibilities
Be responsible for managing clinical projects to ensure the successful delivery of all lab services, including kits shipment, sample testing and sample management of a clinical study for the Asia region
Act as regional liaison between Labcorp Central Lab Services (CLS) Global Study Manager and various CLS departments involved in the clinical protocol
Close collaboration with the Global Study Manager for all study related aspects that are pertaining to the Asia platforms and through all study stages, from set-up to closure
Review the study Statement of Work, a document that specifies the scope of services CLS will perform for a clinical protocol and contains information approved by the sponsor and necessary to define the protocol specific database, to ensure regional feasibility and make appropriate recommendations to the Study Design Lead
Ensure a detailed knowledge of the Statement of Work specifications and very good understanding of how they impact every lab services aspect of the clinical trial
Manage day-to-day regional study related activities, including responding and resolving challenges in logistics, lab tests resulting, monitoring and study supplies, keeping the Global Study Manager informed of any study development
Monitor, track and provide resolution to all local study issues, keeping the Global Study Manager in the communication loop
Responsible for implementing monitoring and setting up of local performance metrics and taking corrective actions when needed
Liaise with the Global Study Manager for any tasks assigned to the Regional Study Coordinator as part of the Global Monitoring Plan
Demonstrate ability to work in a matrix environment where task assignments can be channeled down to be completed by Regional Study Coordinators while other task assignments will need to be delegated to other functional groups; demonstrate flexibility in handling both categories of tasks
Participate in functional meetings, learning forum and provide input, keeping processes up to date
Support a culture of continuous improvement, quality and productivity
Support CLS Global Project Management strategy and deliver outstanding customer satisfaction and performance
Thrive personally and professionally at Labcorp Working at Labcorp, you’ll continue to grow in our learning-based culture so you’ll know how to expertly respond and adapt as the industry continues to evolve. Here, you’ll put your education to work as you play a meaningful role in advancing healthcare and making a difference in people’s life.
In addition, Labcorp offers great benefits, global experience and the opportunity to work independently within a team-oriented environment.
What we’re looking for Regional Study Coordinators
are the most successful at Labcorp with:
Bachelor Degree in relevant fields.
Relevant professional / internship experience in clinical research or pharmaceutical industry will be an advantage
Ability to use computer and office software applications (e.g. Microsoft Word, Excel, MS-Access and Outlook)
Strong interpersonal skills
Influence and negotiation skills
Demonstrated ability to plan and prioritize
Demonstrated communication and organizational skills
Demonstrated attention to detail
Proven ability to excel in a fast paced environment
Proven teamwork
Proven experience and knowledge of processes and tools used in department
Demonstrated ability to liaise with internal departments
Demonstrated ability to facilitate meetings
Demonstrated participation in process improvement initiatives
Liaising with China counterparts is expected, proficiency of Chinese is essential
Get to know Labcorp At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations.
Here, you can join our more than 60,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives.
Equal Opportunity Labcorp is proud to be an Equal Opportunity Employer: Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, family or parental status, marital status, civil union or domestic partnership status, sexual orientation, gender identity, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.
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Regional Study Coordinator
Posted 16 days ago
Job Viewed
Job Description
Labcorp Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia Join to apply for the
Regional Study Coordinator
role at
Labcorp . Join our talent pool for future needs! Are you interested in making a real scientific impact through your everyday work? Would you enjoy working in a team-focused environment as you explore unique career opportunities? If you are looking for a company where you can personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view, consider working at Labcorp as a
Regional Study Coordinator . Responsibilities
Be responsible for managing clinical projects to ensure the successful delivery of all lab services, including kits shipment, sample testing and sample management of a clinical study for the Asia region Act as regional liaison between Labcorp Central Lab Services (CLS) Global Study Manager and various CLS departments involved in the clinical protocol Close collaboration with the Global Study Manager for all study related aspects that are pertaining to the Asia platforms and through all study stages, from set-up to closure Review the study Statement of Work, a document that specifies the scope of services CLS will perform for a clinical protocol and contains information approved by the sponsor and necessary to define the protocol specific database, to ensure regional feasibility and make appropriate recommendations to the Study Design Lead Ensure a detailed knowledge of the Statement of Work specifications and very good understanding of how they impact every lab services aspect of the clinical trial Manage day-to-day regional study related activities, including responding and resolving challenges in logistics, lab tests resulting, monitoring and study supplies, keeping the Global Study Manager informed of any study development Monitor, track and provide resolution to all local study issues, keeping the Global Study Manager in the communication loop Responsible for implementing monitoring and setting up of local performance metrics and taking corrective actions when needed Liaise with the Global Study Manager for any tasks assigned to the Regional Study Coordinator as part of the Global Monitoring Plan Demonstrate ability to work in a matrix environment where task assignments can be channeled down to be completed by Regional Study Coordinators while other task assignments will need to be delegated to other functional groups; demonstrate flexibility in handling both categories of tasks Participate in functional meetings, learning forum and provide input, keeping processes up to date Support a culture of continuous improvement, quality and productivity Support CLS Global Project Management strategy and deliver outstanding customer satisfaction and performance What we’re looking for
Bachelor Degree in relevant fields. Relevant professional / internship experience in clinical research or pharmaceutical industry will be an advantage Ability to use computer and office software applications (e.g. Microsoft Word, Excel, MS-Access and Outlook) Strong interpersonal skills Influence and negotiation skills Demonstrated ability to plan and prioritize Demonstrated communication and organizational skills Demonstrated attention to detail Proven ability to excel in a fast paced environment Proven teamwork Proven experience and knowledge of processes and tools used in department Demonstrated ability to liaise with internal departments Demonstrated ability to facilitate meetings Demonstrated participation in process improvement initiatives Liaising with China counterparts is expected, proficiency of Chinese is essential Get to know Labcorp
At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 60,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Equal Opportunity
Labcorp Is Proud To Be An Equal Opportunity Employer. Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. We encourage all to apply. If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement. Job details
Seniority level: Entry level Employment type: Full-time Job function: Research, Analyst, and Information Technology Industries: Hospitals and Health Care
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Research Manager (Healthcare)
Posted 16 days ago
Job Viewed
Job Description
The Research Manager is a technical expert who oversees all phases of a marketing research study for assigned Healthcare clients by performing the tasks and activities required for a successful study. These include managing local and regional fieldwork and liaising with local affiliates for the successful completion of regional studies. Responsibilities
Assist the Associate Research Director / Director in project management and client servicing for all aspects of our business. This includes generating new client relationships and strategic planning to grow the local healthcare business. Assist in writing proposals and questionnaire design. Participate in client pitches and capabilities meetings as well as sourcing new business through multiple channels. Manage regional projects in terms of fieldwork management, data delivery and generating charts for reports. This entails: Assist in the sending out of regional RFQs and negotiating with local offices on fieldwork. Conduct fieldwork briefing, coordination and monitoring for regional projects. Manage QC process for both fieldwork and data-processing. Conduct and manage resources for checking tables and charting. Ensure fieldwork and data quality for regional projects. Ability to supervise and mentor junior level staff (Senior Researcher and below). Report writing and presentation of findings. Qualifications
Minimum 3-4 years market research experience, especially regional market research experience - Healthcare market research experience is not essential. Required Skills
Excellent client servicing skills, including the ability to communicate confidently with clients (via written, telephone and face to face). Excellent organisational, problem solving and project management skills. Excellent written and verbal communication skills with the ability to effectively interact with internal and external clients. Strong analytical skills. Initiative to change and suggest change to help improve how the team and organisation function. Preferred Skills
Healthcare market research experience is not essential. Job details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Research, Consulting, and Business Development Industries: Market Research Referral and similar notices listed in the original posting contain general employer branding content and other roles; those sections have been omitted to focus on the core role information.
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Graduate Research Coordinator
Posted 2 days ago
Job Viewed
Job Description
Opportunity The Graduate Research Office at Monash University Malaysia is excited to announce an opportunity to join the team as a Graduate Research Coordinator. In this role, you will be responsible for a broad range of administrative support services within the Graduate Research Office. The incumbent will ensure the seamless operation of the admission process and enhance the overall efficiency of the office by delivering high‑quality service to both prospective and current students and staff.
Reporting Line The position reports to the Graduate Research Specialist, Graduate Research Office, under broad direction.
Responsibilities
Provide administrative support for graduate admissions processes.
Ensure seamless operation of the admission process.
Deliver high‑quality service to prospective and current students.
Maintain accurate student records.
Coordinate communications between students and staff.
Contribute to efficiency improvements in office operations.
Application Process Your application must address the selection criteria. For instructions on how to apply, please refer to “How to apply for Monash Jobs”.
For further enquiries, email:
Applications must be submitted via the official career site. Resumes sent to the email address will not be considered.
Job Closing Date 07 November :55 pm MYT
Monash University Malaysia reserves the right to delay or not to proceed with an appointment for the above‑mentioned position.
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Graduate Research Coordinator
Posted 4 days ago
Job Viewed
Job Description
Job no:
Work type:
Continuing (Full-time) Location:
Main campus - Malaysia Categories:
Research (Admin Support)
Graduate Research Coordinator Job No.:
School/Unit: Monash University Malaysia Graduate Research Office
Location: Main Campus
Employment Type: Full-time
Duration: Continuing
Amplify your impact at a world top 50 University
Be surrounded by extraordinary ideas - and the people who discover them
At Monash, work feels different. There’s a sense of belonging, from contributing to something groundbreaking – a place where great things happen.
We value difference and diversity, and welcome and celebrate everyone's contributions, lived experience and expertise. That’s why we champion an inclusive and respectful workplace culture where everyone is supported to succeed.
The Graduate Research Office at Monash University Malaysia is excited to announce an opportunity to join the team as a Graduate Research Coordinator.
In this role, the Graduate Research Coordinator will be responsible for a broad range of administrative support services within the Graduate Research Office. The incumbent will ensure the seamless operation of the admission process and enhance the overall efficiency of the office by delivering high-quality service to both prospective, current students and staff.
Reporting line: The position reports to the Graduate Research Specialist, Graduate Research Office, under broad direction.
Why work with us? Discover the advantages of working with us and why we’re the ideal choice for your career. Explore the benefits we offer here.
For further enquiries, please email us at
Please submit all applications via our official career site. Resumes submitted to this email address will not be considered.
Monash University Malaysia reserves the right to delay or not to proceed with an appointment for the above-mentioned position.
Job Closing Date 07 November :55 pm MYT
Advertised:
23 Oct 2025 Singapore Standard Time
Applications close:
07 Nov 2025 Singapore Standard Time
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Clinical Research Associate
Posted today
Job Viewed
Job Description
Best Companies to Work for in 2019
by HR Asia • We were awarded
‘Sponsor of the Year’
in 2019, 2020, 2022 and 2024 from Clinical Research Malaysia for the highest number of studies and total study value recorded in the country! • We have a proud legacy of turning breakthrough science into medicines and vaccines that save and improve lives around the world. We are focused on discovering new solutions for today and the future! • Join the premier biopharmaceutical company that has been in the business for more than
125 years The role is accountable for performance and compliance for assigned protocols and sites in a country.
Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company’s policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems.
Responsibilities include, but are not limited to:
• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. • Performs clinical study site
management/monitoring
activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. • Gains an in-depth understanding of the study protocol and related procedures. • Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready. • Participates & provides inputs on site selection and validation activities. • Performs remote and on-site monitoring & oversight activities using various tools to ensure: o Data generated at site are complete, accurate and unbiased. o Subjects’ right, safety and well-being are protected. • Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. • Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out. • Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. • Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed. • Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites. • Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. • Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as
appropriate/required. • Supports and/or leads audit/inspection activities as needed. • Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities. • Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.
Extent of Travel:
• Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling 2-3 days/week. • Current driver’s license preferred (Must have in certain countries). Qualifications, Skills & Experience CORE Competency Expectations: • Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively. • Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines. • Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. • Hands on knowledge of Good Documentation Practices. • Proven Skills in Site Management including management of site performance and patient recruitment. • Demonstrated high level of monitoring skill with independent professional judgment. • Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices. • Ability to understand and analyse data/metrics and act appropriately. • Capable of managing complex issues, works in a solution-oriented manner. • Performs root cause analysis and implements preventative and corrective action. Behavioural Competency Expectations: • Effective time management, organizational and interpersonal skills, conflict management, problem solving skills. • Able to work highly independently across multiple protocols, sites and therapy areas. • High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment. • Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships. • Demonstrates commitment to Customer focus. • Works with high quality and compliance mind-set. • Positive mindset, growth mindset, capable of working independently and being self-driven. • Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices. Experience Requirements: Required: • Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO. Educational Requirements: Preferred: • B.A./B.S. with strong emphasis in science and/or biology. What we look for … Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Current Employees apply
HERE Current Contingent Workers apply
HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular
Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid
Shift: Valid Driving License: Hazardous Material(s): Required Skills: Accountability, Accountability, Adaptability, Adverse Event Reporting System, Biopharmaceutical Industry, Biopharmaceuticals, Clinical Medicine, Clinical Research Methods, Clinical Sciences, Clinical Site Management, Clinical Study Management, Clinical Testing, Clinical Trial Planning, Clinical Trials Monitoring, Data Analysis, Data Reporting, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Healthcare Innovation, Management Process, Medical Research, Monitoring Control, Organizational Performance Management, Problem Solving, Protocol Adherence {+ 4 more}
Preferred Skills: Job Posting End Date: 07/15/2025
*A job posting is effective until 11:59:59PM on the day
BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day
BEFORE
the job posting end date.
Requisition ID: R
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Clinical Research Associate
Posted today
Job Viewed
Job Description
Best Companies to Work for in 2019
by HR Asia We were awarded
‘Sponsor of the Year’
in 2019, 2020, 2022 and 2024 from Clinical Research Malaysia for the highest number of studies and total study value recorded in the country. We have a proud legacy of turning breakthrough science into medicines and vaccines that save and improve lives around the world. We are focused on discovering new solutions for today and the future. Join the premier biopharmaceutical company that has been in the business for more than
125 years The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company’s policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems. Responsibilities include, but are not limited to: Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Gains an in-depth understanding of the study protocol and related procedures. Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready. Participates & provides inputs on site selection and validation activities. Performs remote and on-site monitoring & oversight activities using various tools to ensure:
Data generated at site are complete, accurate and unbiased. Subjects’ right, safety and well-being are protected.
Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out. Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed. Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites. Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required. Supports and/or leads audit/inspection activities as needed. Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities. Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate. Extent of Travel: Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~2-3 days/week. Current driver’s license preferred (Must have in certain countries). Qualifications, Skills & Experience CORE Competency Expectations: Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively. Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines. Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. Hands on knowledge of Good Documentation Practices. Proven Skills in Site Management including management of site performance and patient recruitment. Demonstrated high level of monitoring skill with independent professional judgment. Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices. Ability to understand and analyse data/metrics and act appropriately. Capable of managing complex issues, works in a solution-oriented manner. Performs root cause analysis and implements preventative and corrective action. Behavioural Competency Expectations: Effective time management, organizational and interpersonal skills, conflict management, problem solving skills. Able to work highly independently across multiple protocols, sites and therapy areas. High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment. Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships. Demonstrates commitment to Customer focus. Works with high quality and compliance mind-set. Positive mindset, growth mindset, capable of working independently and being self-driven. Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices. Experience Requirements: Required: Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO. Educational Requirements: Preferred: B.A./B.S. with strong emphasis in science and/or biology. Merck & Co., Inc. is an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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Clinical Research Associate
Posted 2 days ago
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Job Description
Schedule and manage subject visits, including unscheduled visits, as per protocol requirements.
Recruit, consent, screen, instruct, and coordinate research subjects.
Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Dexcom’s SOPs.
Identify and escalated safety events and major protocol deviations.
Assist with assessing trends for safety and protocol deviations and communicate findings to the PI. Propose and implement corrective and preventative actions.
Trial Planning and Coordination Provide documents and information for Ethics Committee applications.
Perform tasks as delegated by the Principal Investigator in accordance with the protocol, SOPs, and applicable guidelines.
Assist in finding potential subjects through pre‑screening activities.
Prepare supplies and account for devices required for clinical studies.
Set up IT equipment for studies.
Develop clinical study materials (including, but not limited to, source documentation, IRB submissions, training slides, etc.).
Data Collection and Management Ensure timely and accurate completion of Case Report Forms (CRF/e‑CRF) and resolve queries.
Maintain essential study documents/files and make records available for review, including device accountability tracking.
Keep an ongoing record and assessment of adverse events (AEs) and serious adverse events (SAEs).
Assist with departmental audits of clinical studies and procedures.
Compliance and Ethics Ensure trial practices reflect ethical and legal standards for clinical trials.
Adhere to all Dexcom SOPs, ISO 14155:2020, and Malaysian Guideline for Good Clinical Practice.
Notify the Ethics Committee of SAEs and protocol deviations (PDs).
Prepare the site for monitoring, audit, and inspection, and implement recommended corrective actions.
Administrative Support Observe the progress of trial activities and communicate schedules/required procedures to the team.
Assist with dispensing participants’ compensation (if applicable).
Coordinate trial close‑out activities, including device investigation or disposal and archiving materials.
Involve in and contribute to all quality improvement activities of the department.
Collaborate with global Clinical PMO and study teams to establish and maintain study timelines.
Communicate effectively and professionally with coworkers, leadership, and study subjects.
Collaborate effectively with peers and leadership across departments and professionally interact/build relationships with FDA, IRB, and key opinion leaders.
Perform other duties as assigned under minimal supervision.
Required Qualifications Degree in nursing, sciences, or pharmacy. MBBS/MD with clinical experience will also be considered.
2‑5 years relevant working experience in clinical research.
Possess GCP Certification.
Proficient with MS Office Suite.
Excellent communication skills and ability to work effectively with multiple global functions.
Strong organizational skills and ability to manage competing priorities.
Strong critical thinking and independence.
Willing to work, hands‑on, in an extremely fast‑paced environment with high attention to details and accuracy.
Preferred Qualifications Experience in continuous glucose monitoring (CGM) or diabetes‑related studies.
Experience working closely with a global team.
Experience with Clinical Trial Management Systems (e.g. Veeva).
Application Questions
How many years' experience do you have as a clinical research associate (CRA)?
Which of the following statements best describes your right to work in Malaysia?
What's your expected monthly basic salary?
Which of the following types of qualifications do you have?
How many years' experience do you have as a Clinical Research Coordinator?
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