Reports to: Project Manager with guidance from the
Principal Investigator and Regulatory Affairs Coordinator
Duty Station: Mityana & Mubende Districts.
Contract terms: one year (renewable)

Required qualifications and Profile:
A registered health professional (e.g. medical officer, pharmacist, pharmaceutical scientist, or nurse (BSN)) with at least 2 years working experience in a busy research institution setting. Prior experience with clinical or implementation science research would be an added advantage. The applicant should be computer literate especially with Microsoft Office packages. The desired person must be someone who pays attention to detail, able to multi – task and willing to work for long hours including weekends whenever the need arises. The person should possess good communication and interpersonal skills and must be an excellent team player. The ideal candidate should also be able to move across other PURPOSE 1 research sites in Masaka, and Entebbe.

The holder of this position will work under the direct supervision of the Principal Investigator and Study Coordinator with support from the Regulatory Affairs Coordination Office and will be responsible for the following duties:
Compliance support to other PURPOSE 1 study sites under the oversight of MUJHU.
• Support development and quality control management of all essential study regulatory documents.
• Review of study documents and identify areas of non –compliance.
• Timely review of participant consents.
• Maintenance of research source and essential documents.
• Ensure timely research submissions including progress reports, serious adverse events, protocol deviations, amendments, DSMB outcome reports etc.
Compliance support to other PURPOSE 1 study sites under the oversight of MUJHU.
• Ensure compliance with regulations set by the Institutional Review Boards and other local and international Regulatory bodies.
• Train and track research staff required trainings based on local, international and sponsor requirements.
Participate in protocol team trainings and meetings
• Remaining up to date with the current study specific protocol and procedures as well as related GCP and human subjects’ Protection requirements and required trainings
• Communication directly with the site and study coordinator /SAE coordinator for any data or participant safety issues
• Provides timely feedback on QC findings to study teams to enable implementation of preventive actions and for overall quality improvement.
• Maintain professional GCLP/HSP accreditation and complete study specific training as required.