CTU Central Regulatory Officer

UZ-CTRC is seeking a suitably trained, competent, and qualified applicant to fill the position of Central Regulatory Officer. The incumbent will be responsible for providing support to the Clinical Research Sites (CRS) within the Clinical Trials Unit (CTU). He/she is expected to enhance efficiency related to Institutional Review Board (IRB) and regulatory authorities’ applications within the CTU and be responsible for process standardization of regulatory work across the CRSs within the CTU, review, and follow-up of all IRB applications prior to submission per sponsor requirements.

RESPONSIBILITIES

• Responsible for submission of all applications to the various IRBs, tracking all submissions and following up directly with the IRB.
• Review of   application   packages   and   approval   letters   for accuracy and completeness, with the help   of   Admin assistants and Coordinators
• Work closely with CRSs to expeditiously resolve or respond to queries raised upon review of submissions made to IRBs and regulatory authorities.
• Ensuring that reminders for renewal applications are sent to IoR, Coordinators and other designated key staff. Use of automated reminders and follow up emails can be utilized.
• Establish electronic Trial Master Files for all studies in the CTU to enable internal virtual QA/QC audits and reviewing the IRB SOP at least once every 12 months.
• Ensure bookings for any pre-submission meetings are done as required.
• Communicates directly with the IRB to get updated information on application requirements, review dates, outcomes, queries, and timelines for query responses; communicates any change or new requirements by the IRB to all CRSs within the CTU.
• Progress tracking of all IRB applications at the CRSs of new and existing protocols.
• Communicates internally with CTU departments such as Accounts for tracking of payments, Pharmacy and Laboratory. Communicates externally with the IRBs to discuss any challenges.
• Raise  payment   request(s) for all regulatory bodies   and Institutional   Review   Boards   and   with a clear indication of the   timeline   for the payment to be made. Communicates progress of IRB applications to the CRS leadership monthly.
• Ensure all applicable protocols have valid clinical trial insurance cover.

Required Qualifications & Experience

• Degree in life Sciences/Social Sciences/Nursing/Pharmacy/Project Management.
• Master’s degree in sciences and management experience in medical research is an added advantage.
• At least 5 years’ experience in research set up; excellent interpersonal and communication skills.

• Excellent organizational, planning, and analytical skills; Ability to influence culture in a team.

• Clean Class 4 driver’s licence.

To apply

Interested candidates should forward applications and detailed curriculum vitae to the below email address not later than Friday 18 March 2023:-

applications@uz-ctrc.org.