Job Summary
Provides regulatory affairs support with administrative maintenance and follow-up. The job holder is responsible for effective documentation and compliance monitoring of research studies.
Overall Responsibilities
- Administrative Support Services
- Review submission packages and facilitate submission to ethical and regulatory bodies.
- Develop and maintain tracking system to assess progress on submission.
- Develop Standard Operating Procedures that streamline regulatory procedures.
- Arrange the timely renewal of practicing license and registration certificates of researchers.
- Prepare payments to regulatory authorities in a timely manner.
- Research Monitoring Support
- Check that all study procedures and reporting are conducted in accordance to the site, protocol, and regulatory guidelines.
- Maintain and store all source documents for the study.
- Followup teams to confirm that SOP, protocol, and regulatory mandated timelines and IRB reviews are followed.
- Participate in internal, regulatory, and compliance monitoring as required.
- Communication &Capacity Building Support
- Correspond with Ethical and Regulatory bodies.
- Provide training for regulatory and protocol related policies to study staff.
- Record Keeping
- The job holder creates and maintains electronic regulatory binders, logging of safety reports, scanning and uploading regulatory documents as well as processing minor amendments.
- Maintain up-to-date regulatory binders.
- Ensure proper filing of study documents in properly labelled files while tracking documents coming and leaving the office.
- Archiving of completed studies documents.
- Reporting
- Provide feedback to regulatory affairs coordinator , about all documentation, submissions and communications.
Required Qualification, Experience and Competencies:
- A Degree in Nursing, Bioethics or related field At least 2 years’ relevant experience in thehealth research sector.
- Registration with the relevant professional body is key
- 2 Years Relevant Experience
