OUCRU Indonesia

OUCRU ID – Regulatory Research Associate – Jakarta

  • Group: Clinical Research Management and Governance, OUCRU Indonesia
  • Location: Jakarta (with frequent travel to sites expected)
  • Hours of Work: 1.0 FTE
  • Tenure: Initially for 01 years with possibility of extension
  • Reporting to: Head of Clinical Research Management and Governance
  • Vacancy Reference: OUCRU ID – Regulatory Research Associate – Jakarta

Background

The Oxford University Clinical Research Unit (OUCRU) is a large-scale clinical and public health research unit, with sites offices in Ho Chi Minh City and Hanoi in Vietnam, Jakarta in Indonesia and Kathmandu in Nepal. In Vietnam, we are hosted by the Hospital of Tropical Diseases (HTD) in Ho Chi Minh City, and the National Hospital for Tropical Diseases (NHTD) in Hanoi. OUCRU Nepal closely collaborates with the National Academy of Medical Sciences in Kathmandu, and OUCRU Indonesia exists in partnership with the Universitas Indonesia. As a Wellcome Trust Africa Asia Programme, we have received considerable support from the Wellcome Trust since our establishment in 1991.  

OUCRU’s vision is to have local, regional and global impact on health by leading a locally driven research programme on infectious diseases in Southeast Asia. Priority is given to health issues important to the hospitals where we work, and to the countries as a whole where we operate: Vietnam, Indonesia and Nepal.  All work is intended not only to benefit the patients seen daily at our host hospitals, but also to help improve patient care. 

Please see more information on OUCRU website: www.oucru.org 

Key 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

Requirements

  • Bachelor Degree (Registered Pharmacist)
  • Work experience: Minimum 2 years in Regulatory Affairs (pharmaceutical company, clinical research organisation) and/or community or clinical pharmacy
  • 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

How to Apply

Please submit the following documents by email to recruitment.id@oucru.org:

  • Cover letter
  • Curriculum vitae
  • Names and contact details of a minimum of two professional referees
  • Salary expectations

Email Subject: Please quote the reference “OUCRU ID – Regulatory Research Associate – Jakarta – Your name” 

Deadline for submission: 21 August 2026

Only shortlisted candidates will be contacted.

Contact person

Iwan Tarmizi/Eka Yuninda

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