LOCATION
Oxford University Clinical Research Unit, Jakarta, Indonesia, with frequent travel to sites expected
ABOUT OUCRU INDONESIA
The Oxford University Clinical Research Unit in Indonesia (OUCRU ID; formerly EOCRU) operates in partnership with the Faculty of Medicine Universitas Indonesia. OUCRU ID is part of the Major International Programme Vietnam sponsored by the Wellcome and governed by the Centre for Tropical Medicine and Global Health at the Nuffield Department of Medicine, University of Oxford, United Kingdom. OUCRU in Indonesia and Vietnam, along with their many local and international partners, conduct biomedical, clinical, and epidemiological research on infections impacting the health of people living in Southeast Asia and beyond.
KEY TASKS AND RESPONSIBILITIES
System and Communication Tools Management
- Sets up, populates and accurately maintains information in OUCRU ID tracking and communication tools (e.g. CTMS, NAS, SharePoint, etc.) and supports others in the usage of these systems
Study Document Management
- Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF, including document tracking in accordance with ICH- GCP and local requirements.
- Ensures essential documents under their responsibility are of quality and maintain Inspection Readiness
- Contributes to the production and maintenance of study documents, ensuring template and version compliance.
- Ensures that all study documents are ready for final archiving and completion of local part of the TMF and supports the CTC in the close out activities for the ISF.
Regulatory and Study Authorization
- Contributes to clinical research applications/submissions by handling clinical-regulatory documents according to the requested technical standards and supporting delivery to regulatory authorities.
- Interfaces with Local Study Team and Clinical Trial Coordinators during the document collection process to support effective delivery of a study and its documents.
- Assists in coordination and administration of clinical studies from the start-up to execution and close-out.
- Collects, assists in preparation, reviews and tracks documents for the application process.
- Assists in timely submission of proper application/documents to OxTREC, EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study.
- Support Senior Research & Grant Administrator to prepare, submit, track and document applicable permits required by the respective research (including local research permit, import permit etc.)
- Ensures compliance with local, national and regional legislation, as applicable.
IMP management
Act as Clinical Trial Pharmacist back up:
- Supports the Clinical Trial pharmacist in reviewing protocols and study documents related to investigational drug management;
- Liaise with study team and/or coordinator to establish site pharmacy's role, and to implement dispensing, compounding and billing procedures;
- Maintaining Pharmacy Binder;
- Ensures and coordinates distribution of an up-to-date investigational drug trials list and stock at OUCRU ID;
- Ensures that the investigational drug is handled, stored, identified and dispensed in accordance with the applicable requirements and quality standards;
- Ensures the accountability through good documentation practice in all activities related to investigational drug management; and
- Liaise with the hospital and/or health facility pharmacy involved in storage and distribution of investigational drug;
ESSENTIAL CRITERIA
- Bachelor's degree in Pharmacy or a related pharmaceutical field
- Experience in clinical trial regulatory and QA activities
- Knowledge in document management
- Excellent English scientific writing and communication skills
- Ability to work effectively in matrix environment
- Good to excellent command of English (CEFR B2–C1); fluency in both written and spoken English is preferred
GROUP
Clinical Research Operations Services
HOURS OF WORK
Full-time
TENURE
Initially for 01 year with possibility of extension
VACANCY REFERENCE
JDID-0826-013
HOW TO APPLY
Please quote the reference OUCRU ID – REGULATORY RESEARCH ASSOCIATE-JAKARTA – Jakarta – Your name in your email subject.
Please submit the following documents by email:
· Cover letter
· Curriculum vitae
· Names and contact details of a minimum two professional referees
· Salary expectations
Applications should be sent to: [Confidential Information]
*** We thank all candidates for their interest but only short-listed applicants will be notified for interview.
Contact person: Iwan Tarmizi/ Eka Yuninda
Deadline for submission: 31 August 2026
