Job Title: Administrative Assistant (Regulatory Affairs) – Baylor College Uganda Jobs 2021

Organization: Baylor College of Medicine Children’s Foundation Uganda (Baylor-Uganda)

Job Location: Kampala, Uganda

 

 

Baylor College of Medicine Children’s Foundation Profile:

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.

 

 

Roles 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.

 

 

Minimum Qualifications:

  • 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 for Baylor College Uganda Jobs 2021

All interested and suitably qualified candidates should submit their applications through the link below.

Click here to apply

Deadline: 5th November 2021

 

 

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