Clinical Trial Coordinator

6 months ago


Kuala Lumpur, Malaysia Thermo Fisher Scientific Full time

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.
- Discover Impactful Work:
Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. Provides administrative support for site activation activities. Aids the development of the critical path for site activation within assigned projects in support of rapid site activations. Represents CRG personnel. May use local knowledge, organization systems, external site lists and sponsor directives to develop and review site lists that are suitable for the strategic needs of feasibility activities and to provide local input into the site tiering process. May act as a buddy during onboarding phase and provide training to new staff as needed.
- A day in the Life:
- According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.
- Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
- Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads.
- Provides system support (i.e., Activate & eTMF) and ensures system databases are always current.
- Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
- Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
- Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
- Assists with study-specific translation materials and translation QC upon request.
- Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
- Where applicable, conducts on-site feasibility visits (APAC only).
- May support scheduling of client and/or internal meetings.
- May review and track of local regulatory documents.
- May provide system support (i.e., Activate & eTMF).
- May support RBM activities.
- May support the maintenance of study specific documentation and systems, including, but not limited to, study team lists, tracking of project specific training requirements, system access management and activity plans in appropriate system(s).
- Transmits documents to client and centralized IRB/IEC.
- Maintains vendor trackers.
- Supports start-up team in Regulatory submissions.
- Works directly with sites to obtain documents related to site selection.
- Assists the project team with the preparation of regulatory compliance review packages.
- Provides support as needed to coordinate with internal departments, ensuring site start-tup activities within the site activation critical path are aligned.
- May complete the ‘Site Interest Plan’ in CTMS and collection and delivery of associated documents from investigators and site personnel.
- Documents in real time all communication, attempts a follow up associated with site contact and survey responses.
- Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked.
- Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Communicate with the team and appropriate clinical personnel regarding site issues and risks.
- Ensures an efficient, effective plan is in place for site contact and follow up. Ensure



  • Kuala Lumpur, Malaysia Thermo Fisher Scientific Full time

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Local Trial Manager

    7 months ago


    Kuala Lumpur, Malaysia Novasyte Full time

    As Local Trial Manager you will be responsible for local management of a clinical trial in a country or countries, managing the operational aspects of projects to meet contractual requirements. You will act as primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up to close out at a country level in...


  • Kuala Lumpur, Malaysia Novasyte Full time

    Job Overview CTEs collaborate with research staff and other stakeholders to drive trial recruitment and to support study specific training needs. The CTE acts as a strategic partner to both external and internal stakeholders to optimise the site experience and performance. Leads the relationship management and communication of medical and scientific...


  • Kuala Lumpur, Malaysia Novotech Asia Full time

    **Brief Position Description**: The Clinical Contracts Specialist (CC Specialist)/ Senior Clinical Contracts Specialist (SCC Specialist) is responsible for the timely development of investigator grants and Clinical Trial Agreement templates during the start-up stage of a Clinical Trial. The CC Specialist/ SCC Specialist will work closely with Project...


  • Kuala Lumpur, Malaysia RF Staffing and Outsourcing Solutions Sdn. Bhd. Full time

    Responsibilities: - Initiate investigator site activities, including collection and submission of regulatory documents to Ethics Review Board and Competent Authority, communicate and negotiate budgets and contracts with site, track and ensure site compliance to required effectively drive timelines aligned with company priority. - Communicate with sites,...


  • Kuala Lumpur, Malaysia Thermo Fisher Scientific Full time

    At **Thermo Fisher Scientific**, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond...


  • Kuala Lumpur, Malaysia RF Staffing and Outsourcing Solutions Sdn. Bhd. Full time

    JOB SCOPE - Initiate investigator site activities, including collection and submission of regulatory documents to Ethics Review Board and Competent Authority, communicate and negotiate budgets and contracts with site, track and ensure site compliance to required training and effectively drive timelines aligned with company priority. - Communicate with sites,...

  • Research Coordinator

    6 months ago


    Kuala Lumpur, Malaysia RF Staffing and Outsourcing Solutions Sdn. Bhd. Full time

    JOB SCOPE - Initiate investigator site activities, including collection and submission of regulatory documents to Ethics Review Board and Competent Authority, communicate and negotiate budgets and contracts with site, track and ensure site compliance to required training and effectively drive timelines aligned with company priority. - Communicate with sites,...


  • Kuala Lumpur, Malaysia Thermo Fisher Scientific Full time

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...


  • Kuala Lumpur, Malaysia Thermo Fisher Scientific Full time

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...


  • Kuala Lumpur, Malaysia Novo Nordisk Full time

    Clinical Research Associate **Category**:Clinical Development**Location**:Kuala Lumpur, Kuala Lumpur, MY- **Joining a Talent Pipeline in Novo Nordisk**- **About the department** - The Clinical, Medical, and Regulatory (CMR) department is one of the key functions that enable the business strategy through the effective execution of functional goals, in the...

  • Business Consultant

    7 months ago


    Kuala Lumpur, Malaysia GP Outsourcing Asia Full time

    1. Familiar with the general requirements of international clinical trials (ICH-GCP), and track the latest clinical trial methodological progress; 2. Search the local language and English literature related to the research product; 3. Participate in the writing of the experimental protocol (English version) of the research project; 4. Participate in clinical...


  • Kuala Lumpur, Malaysia Novasyte Full time

    Direct a team of clinical professionals to support and deliver clinical research projects in Singapore and Malaysia, ensuring that projects are effectively resourced and that teams are effectively trained and managed to deliver successful outcomes to customers. Work with senior leadership in formulating and executing effective strategic goals and objectives...


  • Kuala Lumpur, Malaysia METRO IVF Full time

    Andrologist / Clinic Coordinator (Female ONLY) JOB RESPONSIBILITIES: 1. To provide high standards of patient-centered care and explanations of available infertility treatment/a (IUI, IVF etc) 2. To liaise with the multi-disciplinary team comprising of doctors and nurses in the care of patients. 3. To ensure effective communication within the department on...


  • Kuala Lumpur, Malaysia BIOTRONIK SE & Co. KG Full time

    BIOTRONIK is one of the leading manufacturers of cardio - and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success...


  • Kuala Lumpur, Malaysia BIOTRONIK Full time

    BIOTRONIK is one of the leading manufacturers of cardio - and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success...


  • Kuala Lumpur, Malaysia Prevent Plus Sdn Bhd Full time

    **URGENT HIRING!!! URGENT HIRING!!! URGENT HIRING!!!** **Job Title: Clinic Supervisor/Clinic Assistant** **Industry: Healthcare** **Years of Working Experience: Preferred 1 year of experience in any related field.** We are seeking a motivated and detail-oriented individual to join our healthcare team as a Clinic Supervisor/Clinic Assistant. You will be...

  • Clinic Supervisor

    7 months ago


    Kuala Lumpur, Malaysia Biopower Sdn Bhd Full time

    **Job Title: Clinic Supervisor** **Company**: Klinik Dr. Leela Ratos **Location**: Pudu, Kuala Lumpur Join our team at Klinik Dr. Leela Ratos as a Clinic Supervisor and take charge of our in-house GP clinic operations. We are seeking an experienced individual who can effectively manage clinic software, liaise with doctors, and drive marketing initiatives...

  • Clinic Admin Assistant

    3 months ago


    Kuala Lumpur, Malaysia Dytan Health On-Line Full time

    **Company Overview**: Good Clinic (a division of Health On-line) is an innovative healthcare and telemedicine company with a bold vision to transform the future of healthcare through integrative medical services. Our mission is to bridge the gap between healthcare providers and patients, offering a seamless and personalized experience. We are committed to...


  • Kuala Lumpur, Malaysia IFloss Dental Full time

    Clinic Operational Manager **Position**:Clinic Operational Manager **Reports To**:Clinic Director **Job Overview**: **Key Responsibilities**: **Operational Management**: - Oversee daily operations of all three clinic branches to ensure efficiency and effectiveness. - Coordinate with different departments to streamline processes and improve patient...