Job Title: Administrative Assistant, Regulatory Affairs
Organisation: Baylor College of Medicine Children’s Foundation -Uganda
Duty Station: Kampala, Uganda
About US:
Baylor College of Medicine Children’s Foundation -Uganda (Baylor-Uganda) is an indigenous not-for-profit child health and development organisation affiliated to the Baylor College of Medicine International Paediatric AIDS Initiative (BIPAI), a Network of paediatric HIV/AIDS care and treatment Children’s Clinical Centres of Excellence and international program offices in 11 countries across Africa and Eastern Europe.
Job Summary: Provides regulatory affairs support with administrative maintenance and follow-up. The jobholder is responsible for effective documentation and compliance monitoring of research studies.
Key Duties and 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.
Qualifications, Skills and Experience:
- The ideal applicant must hold Degree in Nursing, Bioethics or related field
- Registered with the relevant professional body is key
- At least two of relevant work experience
How to Apply:
All Interested applicants should apply online at the link below
Deadline: 5th November 2021
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