The Eijkman-Oxford Clinical Research Unit (EOCRU) in Jakarta opened in 2008 with the signing of a memorandum of understanding between the Eijkman Institute for Molecular Biology and the University of Oxford, to conduct collaborative research on infectious diseases impacting the health of Indonesians and residents of other Southeast Asian nations. University of Oxford also has a partnership (MoU) with Universitas Indonesia, and they jointly established the Universities of Indonesia and Oxford Clinical Research Laboratory (IOCRL) which is a facility dedicated to supporting collaborative clinical research between the universities. EOCRU is also part of the Oxford Tropical Network with research units in Africa, Asia and UK, and operates under the auspices of the Oxford University Clinical Research Unit in Vietnam.
Clinical trials of chemotherapeutics, diagnostics and vaccines for tropical infections of public health importance in Indonesia, principally malaria, tuberculosis, antimicrobial resistance, and other emerging and neglected tropical diseases, form the core of EOCRU’s activities, with associated epidemiological, laboratory, and clinical research. EOCRU aims to have a positive and significant impact on the prevention, diagnosis and treatment of infectious diseases to improve patient care in Indonesia and the region. This is being achieved via an expanding long-term research programme with our local hosts and partners, contributions to research training, and public engagement with science. Current EOCRU core staff includes 3 Oxford-employed international scientists, Indonesian scientists, administrative and finance support staff, and clinical trials support staff.
In conducting their work in Indonesia, EOCRU is assisted by Alliance for Emerging and Re-emerging Disease Threats in Asia Foundation (ALERTAsia), a local foundation assisting in research grant management and capacity building for local researchers.
Through ALERTAsia, we are seeking a qualified and experienced Clinical Research Administrator. S/he will be responsible for study document and system and communication tools management, regulatory and study authorization supporting the Research Regulatory Manager and act as Clinical Trial Pharmacist back up.
Job Descriptions:
System and Communication Tools Management
- Sets up, populates and accurately maintains information in EOCRU tracking and communication tools (e.g., CTMS, NAS, SharePoint, etc.) and supports others in the usage of these systems.
Study Document Management
2. 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.
3. Ensures essential documents under their responsibility are of quality and maintain Inspection Readiness.
4. Contributes to the production and maintenance of study documents, ensuring template and version compliance.
5. 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
6. Contributes to clinical research applications/submissions by handling clinical-regulatory documents according to the requested technical standards and supporting delivery to regulatory authorities.
7. Interfaces with Local Study Team and Clinical Trial Coordinators during the document collection process to support effective delivery of a study and its documents.
8. Assists in coordination and administration of clinical studies from the start-up to execution and close-out.
9. 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.
10. 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.)
11. Ensures compliance with local, national and regional legislation, as applicable.
IMP management
Act as Clinical Trial Pharmacist back-up:
12. Supports the Clinical Trial pharmacist in reviewing protocols and study documents related to investigational drug management.
13. Liaise with study team and/or coordinator to establish site pharmacy’s role, and to implement dispensing, compounding and billing procedures.
14. Maintaining Pharmacy Binder.
15. Ensures and coordinates distribution of an up-to-date investigational drug trials list and stock at EOCRU.
16. Ensures that the investigational drug is handled, stored, identified and dispensed in accordance with the applicable requirements and quality standards.
17. Ensures accountability through good documentation practice in all activities related to investigational drug management.
18. Liaise with the hospital and/or health facility pharmacy involved in storage and distribution of investigational drugs.
Qualifications
Education and Experience
- Bachelor of Pharmacy and Registered pharmacist.
- Minimum of 3-5 years in regulatory affairs (pharmaceutical company, clinical research organization).
- 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.
Required Knowledge and Abilities
- Good Clinical Practice (GCP).
- Good Pharmacovigilance Practice (GVP).
- Good Distribution Practice (GDP).
- Good Manufacturing Practice (GMP).
- Relevant local and global Clinical Trial Regulations.
- Procedural document writing and management.
- Organization skills.
- Interpersonal skills and problem-solving capabilities.
- Strong verbal and written communications skills.
Benefits
The selected candidate will receive a one-year contract with possible extension, and remuneration package that includes annual leave, sick leave, THR, compensation money, optional private medical cover, BPJS Kesehatan, and not to mention fully paid income tax and BPJS Ketenagakerjaan (JAMSOSTEK). The salary shall be competitive and dependent upon qualifications and salary history.
Duty Station
Jakarta
Salary Offer:
Rp. 15.000.000,-
How to Apply
(Please make sure you submit complete requirements to the application)
Interested candidates are invited to send your Cover Letter and Curriculum Vitae by email to hro@alertasia.org with subject line EOCRU_CRA_(Applicant Name)
Please submit your application not later than Friday, 31 March 2022
