Clinical Research Coordinator; OUCRU – CRO PRYSMA

LOCATION

Oxford University Clinical Research Unit, Jakarta, Indonesia, with frequent travel to sites expected.

The Oxford University Clinical Research Unit in Indonesia (OUCRU ; formerly EOCRU) operates in partnership with the Faculty of Medicine Universitas Indonesia.

OUCRU  part of the Major International Programme Vietnam sponsored by the Wellcome and governed by the Centre for Tropical Medicine and Global Health at the Nuffield Department of Medicine, University of Oxford, United Kingdom.

OUCRU in Indonesia and Vietnam, along with their many local and international partners, conduct biomedical, clinical, and epidemiological research on infections impacting the health of people living in Southeast Asia and beyond.

• Develop and maintain clinical research implementation plan, timelines, budget and progress reports as required by OUCRU , sponsors and collaborators.
• Ensure milestones and project work are met within agreed times and budgetary framework.
• Liaise with Finance and Operations Department regarding the budget management and procurement process.
• Draft and monitor the progress of clinical research agreements with collaborators, in collaboration with relevant roles and stakeholders.
• Manage relationship effectively with the members of each clinical research/study team, sponsor, relevant authorities and sites to ensure the successful implementation of each study/trial.
• Act as the liaison between study sites, the clinical research support facility, and the Principal Investigator ensuring open and efficient communications of essential information.
• Organize training, meetings and other activities with study staff, through a combination of meetings in person and via teleconference to facilitate communication and ensure study milestones are achieved in a timely manner.
• Support the regulatory team in the preparation of clinical research applications, agreements and responses to, and reports for the relevant authority bodies and ethics committee.
• Conduct oversight including self-monitoring and evaluation of the implementation of clinical trial at site level, and ensure all deviations and/or findings are reported and addressed in a timely manner.
• Conduct site initiation and close out visits.
• Maintain accurate documentation of all study-related activities in accordance with applicable standards and regulations.
• Ensure clinical research compliance at all times with protocol and applicable regulatory, internationally accepted guidelines for Good Clinical Practice in research (ICH-GCP).
• Take on other tasks as assigned or delegated by the line manager.

• Pharmacist or Medical Doctor or MSc/PhD in Life Sciences.
• Minimum of 2 years of clinical trial and/or drug development experience.
• At least 1 year of clinical research project management/coordination as a Clinical Research Associate or Monitor with clear evidence of delivery.
• Experience with documentation management and data entry required.
• Familiarity with clinical trials, regulatory processes, or research operations highly desirable.
• Experience with CTMS platforms, electronic regulatory systems, or invoicing systems is an advantage.
• Demonstrated experience in working with cross‑functional teams.
• Good knowledge of Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), relevant local and global Clinical Trial Regulations, familiarity with local diseases guidelines and patient management standards, project management skill, organization skills, interpersonal skills and problem‑solving capabilities, strategic agility, strong verbal and written communication skills.

The remuneration package includes annual leave, sick leave, THR, optional private medical cover, BPJS Kesehatan, BPJS Ketenagakerjaan.

Other responsibilities and benefits are based on Indonesia Labor Law.

Clinical Research Operations Services

Hours of work: 1.0 FTE.

Tenure: 1 year, with possibility of renewal.

Reporting to:
Head of Clinical Research Operations Services.

Vacancy reference: JDID-.

• Cover letter.
• Curriculum vitae.
• Names and contact details of a minimum two professional referees.
• Salary expectations.

Applications should be sent to: recruitment.. Only shortlisted candidates will be contacted. Applications that do not include the required reference in the email subject line will not be processed.

We thank all candidates for their interest but only short‑listed applicants will be notified for interview.

Contact person:
Iwan Tarmizi / Eka Yuninda..