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 Trial Monitor. S/he will be responsible to conduct risk assessment, monitoring and manage non-compliance to ensure the data quality and clinical research conducted at EOCRU is in compliant with GxP, local and other applicable regulations.
Job Descriptions:
1. Build a good relationship with study sites and act as a liaison between EOCRU and sites.
2. Perform a risk analysis for new studies and develop monitoring plan.
3. Implement the monitoring plan by arranging visits with the study site based on study progress.
4. Conduct monitoring visits to verify compliance of study conduct with the required guidelines and study plans including (but not limit to):
· Confirm that the site has adequate qualifications and resources to start the study.
· Ensure all study staff at the site has a clear and accurate understanding of how the study is to be conducted.
· Verify that each participant or their representative has given informed consent to participate in the study.
· Verify participant eligibility.
· Confirm accuracy and completeness of source documents and CRFs.
· Verify the reporting of safety events and protocol non-compliance.
· Verify investigational product records and inventory.
· Ensure maintenance of essential documents.
· Train site staff on ICH GCP guidelines, the study protocol and study procedures.
· Write monitoring reports to summarize findings at a site.
· Meet with study staff to explain findings and support staff to correct non-compliance.
5. Contribute to the development of CTU systems, procedures and documentation, especially those relating to monitoring and quality management.
6. Other tasks as assigned by the line manager.
Job Qualifications:
Education and Experience:
- Degree in Life Science, Medicine, Pharmacy, Public Health or related field.
- Experience in conduct, coordinating or monitoring of clinical research.
- Minimum of 3-5 years’ work experience as Clinical Trial Monitor or Clinical Research Associate (pharmaceutical company, clinical research organization).
- Experience in clinical trial regulatory and QA activities.
- Scientific and/or clinical knowledge needed to monitor the trial adequately.
- Excellent English scientific writing and communication skills.
- Ability to work effectively in matrix environment.
Required Knowledges and Abilities:
- Good Clinical Practice (GCP).
- Good Pharmacovigilance Practice (GVP).
- Good Distribution Practice (GDP).
- Good Manufacturing Practice (GMP).
- Good Clinical Laboratory Practice (GCLP).
- Relevant local and global Clinical Trial Regulations.
- Procedural document writing and management.
- Organization skills.
- Self-starter, detail-oriented, good time management, flexible and adaptable.
- 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.
Salary Offer:
Rp. 26.000.000,-
Duty Station
Jakarta
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_CTM_(Applicant Name)
Please submit your application not later than Friday, 31 March 2022
Thank you.
