Job Title: Regulatory Affairs Officer
Organisation: Joint Clinical Research Centre (JCRC)
Duty Station: Kampala, Uganda
About Organisation:
The Joint Clinical Research Centre (JCRC) is an indigenous medical organization that was established in 1991 as a limited liability not-for-profit Joint-venture between the Uganda Ministry of Health (MoH), Ministry of Defense and Makerere University Medical School (now Makerere University College of Health Sciences). JCRC is located on plot 101 Lubowa Hill Off Entebbe Road P.O. Box 10005 Kampala
Job Summary: The Regulatory Affairs Officer will support the Regulatory Affairs Manager in ensuring effective oversight of study protocols, procedures, and adherence to approved quality systems and practices. The incumbent will report directly to the JCRC Regulatory Affairs Manager and collaborate closely with study teams, including Principal Investigators and Study Coordinators, to uphold regulatory standards and facilitate smooth study operations.
Key Duties and Responsibilities:
- Support development and quality control management of all essential regulatory documents.
- Review study regulatory files according to developed schedules.
- Conduct thorough review of study documents to detect non-compliances and support their resolution
- Maintain of all essential study documents in compliance with GCP standards, Sponsor requirements, JCRC policies, and guidance provided by study monitor.
- Review submission packages and facilitate submission to ethical and regulatory bodies.
- Participate in protocol team trainings and meetings
- Maintain research source and essential documents.
- Follow-up on any regulatory pending issues (submission/approvals).
- Maintain and track all research regulatory documentation, including staff training records in Human Subject Protection (HSP) and Good Clinical Practice (GCP), as well as current professional practice licenses and CVs
- Create and maintain electronic regulatory study binders
- Work with study teams on developing the study-specific consent procedures and S.O. Ps
- Review of Informed Consent documents
- Maintain the tracking system for submissions to ethical and regulatory bodies.
- Liaison with the study PIs and study coordinators, take the lead on communications and submissions to ethical, regulatory bodies and Sponsors
Qualifications, Skills and Experience:
- A degree in Nursing or Bioethics or other health related field.
- At least 2 years’ relevant experience in the health research sector.
- Knowledge of MS packages required.
- Maintain high level of personal integrity and reliability. Be willing to work extra/overtime hours as needed according to departmental workload.
- Knowledge of national and international research regulations/guidelines
- Knowledge of bioethics is desirable
- An individual with good communication and interpersonal skills, ability to pay attention to detail, multi -task and an excellent team player
How to Apply:
All applications should be addressed to The Manager Human Resource & Development Joint Clinical Research Centre via [email protected]
Applicants are STRICTLY advised to apply with a cover letter and CV combined in one PDF document not exceeding six pages, quoting clearly the Position in the subject line e.g. Project Manager-Clinical Research.
Label the PDF document with your full name.
Failure to follow the above application procedure will lead to automatic disqualification.
Deadline: 29th August 2025
Note: JCRC is an equal opportunity employer. Any attempts of influencing the recruitment process will lead to automatic disqualification.
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Level of Education: Bachelor Degree
Work Hours: 8
Experience in Months: 24