EOCRU Study Coordinator Malaria Vaccine Trial
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 Study Coordinator for a clinical trial evaluating a malaria vaccine, entitled “Safety and Efficacy of PfSPZ Vaccine and PfSPZ-CVac Against Naturally Transmitted Malaria in Indonesia”.
Study Coordinator (SC) is a specialized research professional, who supports, manages, facilitates, and coordinates the daily clinical trial activities. S/He plays a critical role in the conduct of the study under the supervision of the IOCRL Manager, who is a Senior Clinician Scientist, in Central Jakarta, Indonesia. S/He will also work closely with the trial’s Sponsor Sanaria Inc., a US-based biotechnology company developing vaccines. The trial will recruit a unique study population – a battalion of Indonesian soldiers based in non-malarious Java and being temporarily deployed to a highly malarious area of eastern Indonesia.
The trial investigators delegate day-to-day requirements of the research protocol to the SC in accordance with local authorities and regulations. By performing this statement of work (SOW), the SC works with principal investigator (PI), responsible investigator, co-investigators, department, faculty, institution and sponsor to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical trial. The SC primarily reports to the IOCRL Manager, with associated responsibilities to the IOCRL Study Administrator.
Responsibilities
The general duties and responsibilities are listed below, but not limited to:
Location: UI Salemba Kampus, Jakarta Pusat
Duration: 1 year with possible extension
Note: we will only short list candidates who meet our application requirement.
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 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 Study Coordinator for a clinical trial evaluating a malaria vaccine, entitled “Safety and Efficacy of PfSPZ Vaccine and PfSPZ-CVac Against Naturally Transmitted Malaria in Indonesia”.
Study Coordinator (SC) is a specialized research professional, who supports, manages, facilitates, and coordinates the daily clinical trial activities. S/He plays a critical role in the conduct of the study under the supervision of the IOCRL Manager, who is a Senior Clinician Scientist, in Central Jakarta, Indonesia. S/He will also work closely with the trial’s Sponsor Sanaria Inc., a US-based biotechnology company developing vaccines. The trial will recruit a unique study population – a battalion of Indonesian soldiers based in non-malarious Java and being temporarily deployed to a highly malarious area of eastern Indonesia.
The trial investigators delegate day-to-day requirements of the research protocol to the SC in accordance with local authorities and regulations. By performing this statement of work (SOW), the SC works with principal investigator (PI), responsible investigator, co-investigators, department, faculty, institution and sponsor to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical trial. The SC primarily reports to the IOCRL Manager, with associated responsibilities to the IOCRL Study Administrator.
Responsibilities
The general duties and responsibilities are listed below, but not limited to:
- Coordinate vaccine trial at EOCRU, in collaboration with primary partners at Faculty of Medicine, University of Indonesia; Eijkman Institute for Molecular Biology; Center for Army Health, Indonesian Army, Jakarta, Indonesia; Sanaria Inc., Maryland, US; University of Maryland, US
- Manage and maintain documentation of paperwork, electronic correspondence and data.
- Compliance with all local and institutional rules and regulations related to research involving human subjects and human subject‐derived information and materials, research agreement, monitoring plan, reporting of research findings, any progress or Serious Adverse Event.
- Ensure subject safety by providing information regarding adverse events (AE), severe adverse events (SAE) and any pertinent information to subjects and investigators in a prompt manner.
- Follow up and/or resolve all comments/inputs/findings from authorities, ECs, DSMBs, monitors, collaborators and others.
- Serve as liaison to the chief investigator, site PIs, ethics committees (EC), and government authorities, sponsors, partners/collaborators, Data Safety Monitoring Boards (DSMB) and monitors.
- Oversee, track and maintain financial elements in the study, including budget, payments and invoice the sponsor for completed work.
- Facilitate information exchange among investigators, department, faculty, institution, sponsor, study subjects and/or their representatives, and other support system.
- If required, serve as an advocate for the study subjects and/or co-investigators.
- Communicate with all members of the research team regarding the trial, study subjects or any items related to the conduct of the research.
- The SC will not deviate in any way from the IRB approved protocol.
- Bachelor’s degree in health or biology-related science. Master degree is preferable;
- Experience with coordinating complex projects is essential, and with coordinating clinical trials desirable;
- Fluently speaking and writing in English;
- Computer literacy and proficiency a must.
- Excellent interpersonal skill;
- Ability to manage and/or supervise clinical research activities;
- 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;
- Recognize scope of decision making, with ability to receive directions as appropriate;
Location: UI Salemba Kampus, Jakarta Pusat
Duration: 1 year with possible extension
Note: we will only short list candidates who meet our application requirement.
