The Eijkman-Oxford Clinical Research Unit (EOCRU) 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.
In 2012, the University of Oxford also signed a memorandum of understanding with the Faculty of Medicine Universitas Indonesia and, as part of this MoU, the Universities of Indonesia and Oxford Clinical Research Laboratory (IOCRL) was established. IOCRL, being part of EOCRU, is a research facility that serves as a hub to support clinical trials and other clinical research, education, training and public engagement.
In conducting the 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, EOCRU is seeking a Junior Clinical Trial Administrator.
Overall, A junior Clinical Trials Administrator (CTA) is responsible for the administrative aspects of a number of clinical trials at every stage of the process conducted under EOCRU and its collaboration with both local and international partners. CTA play an essential role in the clinical trial process. S/he will ensure all clinical studies are compliance GCPs and regulatory requirements. S/he prepare, distribute, track and file clinical trial essential documents, implements and maintains clinical filing systems for all shared documents and files at center and local sites. Provides support for the preparation of protocols, agreements, trainings, annual reports , interim updates , Serious Adverse Event (SAE) reports and other study or regulatory documents , as required. S/he works with study teams to prepare clinical study runs smoothly. Handles any import permit related to research projects from regulatory authorities. Performs various administrative duties such as translations, meeting minutes, time sheets for involved investigators and other administrative duties as needed.
PRIMARY RESPONSIBILITIES
Qualifications
Duration: 1 year with possible extension
In 2012, the University of Oxford also signed a memorandum of understanding with the Faculty of Medicine Universitas Indonesia and, as part of this MoU, the Universities of Indonesia and Oxford Clinical Research Laboratory (IOCRL) was established. IOCRL, being part of EOCRU, is a research facility that serves as a hub to support clinical trials and other clinical research, education, training and public engagement.
Through ALERTAsia, EOCRU is seeking a Junior Clinical Trial Administrator.
Overall, A junior Clinical Trials Administrator (CTA) is responsible for the administrative aspects of a number of clinical trials at every stage of the process conducted under EOCRU and its collaboration with both local and international partners. CTA play an essential role in the clinical trial process. S/he will ensure all clinical studies are compliance GCPs and regulatory requirements. S/he prepare, distribute, track and file clinical trial essential documents, implements and maintains clinical filing systems for all shared documents and files at center and local sites. Provides support for the preparation of protocols, agreements, trainings, annual reports , interim updates , Serious Adverse Event (SAE) reports and other study or regulatory documents , as required. S/he works with study teams to prepare clinical study runs smoothly. Handles any import permit related to research projects from regulatory authorities. Performs various administrative duties such as translations, meeting minutes, time sheets for involved investigators and other administrative duties as needed.
PRIMARY RESPONSIBILITIES
- Work with the study coordinator of each projects to ensure that research proposals and protocols meet the requirements, monitoring timelines, obtaining necessary internal and external approvals before the commencement of any research project/proposal, monitoring research execution, to closing the research project.
- Ensure for the compliance of EOCRU’s research activities with the appropriate regulations and research governance, in accordance with Human Research Protection and Good Clinical Practice, including ensuring that all research staff and collaborators complete all necessary trainings before the commencement of research studies.
- Ensure for the compliance of EOCRU’s research activities with the appropriate requirements for research agreements, monitoring plan, reporting of research findings, progress or adverse events and act as liaison to ethics committees/IRBs, government authorities, funders, sponsors, partners/collaborators, Data Safety Monitoring Boards and monitors.
- Responsible for ensuring that all comments or findings from Authorities, Ethics Committees, Data Safety Monitoring Boards, Monitors, Collaborators and others are followed up or resolved.
- Providing advice to investigators/collaborators/research staff in ensure that research projects run smoothly and in compliance with the applicable guidelines and regulations.
- Handling any import permit related to research projects from regulatory authorities.
- Additional tasks assigned by supervisor.
Qualifications
- Extensive experience in administration, experience with coordinating/administrating clinical trials/research is preferable
- Fluently speaking and writing in English as well as Bahasa Indonesia;
- Proficient in MS Word and Excel;
- At least bachelor degree in public health and/or related discipline;
- Excellent interpersonal skill;
- Ability to work effectively as a team with healthcare personnel at all levels;
- Evidence of self-motivation, initiative, creativity and attention to detail;
- Demonstrate high level of organization skills and attention to details;
- Ability to observe, comprehend, analyze and problem solve situations;
Duration: 1 year with possible extension
