REGULATORY RESEARCH ASSOCIATE – JAKARTA

Oxford University Clinical Research Unit (OUCRU) Indonesia also known as Yayasan Jalin Kemitraan Nusantara (YJKN), comprises three research groups and five supporting groups, with a staff of about 120 national staff, including 4 expatriate Oxford staff, located at the Jakarta office and study sites. In addition to our main host institutions above, we also collaborate closely with the broader Oxford Tropical Network, and numerous other international and local partners.

OUCRU Indonesia is currently seeking a qualified and motivated individual to join our team. We are recruiting for the following Jakarta-based position:

Regulatory Research Associate

Department

Clinical Research Operations Services

Position required

Regulatory Research Associate / Back Up Clinical Trial Pharmacist

Quantity

1 FTE

Qualification

Bachelor

Subject

Pharmacist

Work experience

Minimum 2 years in Regulatory Affairs (pharmaceutical company, clinical research organisation) and/or community or clinical pharmacy

Other requirements

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

Working place

Jakarta (with frequent travel to sites expected)

Working time

Full time

Job Description 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.

Duration of employment

1 year (renewable)

How to apply

Application should include CV and cover letter. Professional referees and salary expectations may be requested at a later stage of the recruitment process. Application should be submitted via email to: recruitment.id@oucru.org

Please include the following reference in the email subject line: \" OUCRU ID-REGULATORY RESEARCH ASSOCIATE-JAKARTA-[Your Name] \". Applications that do not include the required reference in the email subject line will not be processed.

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