Job Title: Regulatory Affairs Assistant – Infectious Diseases Institute Jobs 2019
Vacancy Code: RAARX01
Reporting line: Monitoring and Regulatory Officer
Duty Station: Kampala
Infectious Diseases Institute Jobs 2019: The mission of the Infectious Diseases Institute (IDI) is to strengthen health systems in Africa, with a strong emphasis on infectious diseases through research and capacity development. IDI has five operational areas through which it works to achieve its mission: Prevention, Care and Treatment; Training, Research and Laboratory services (provided through a partnership with the Makerere University-John Hopkins University Core Lab) and Outreach.
Key Duties and Responsibilities
- Working closely with the Monitoring and Regulatory Officer (MRO) on all communications, submissions to local and US IRBs and the Sponsors in liaison with the study PI’s and Study Coordinators.
- Assists MRO in planning and conducting training of new and old staff in research regulatory compliance and source documentation (New/ongoing studies).
- Assist the MRO in the development of the QA/QC plan and work closely with the PI’s and CQM chief in developing the site QM plans.
- Quality Control review of the study regulatory files according to Regulatory office schedules.
- Assist the MRO in monitoring the compliance of studies, submitting SAE reports to the local IRB and to other local regulatory bodies.
- In liaison with the MRO, maintain all essential documents across studies according to GCP and Sponsor guidelines, IDI policies and advice/ guidance from study monitors.
- Assist the MRO and PI during external monitoring/Audit.
- Follow-up on any regulatory pending issues (submission/approvals).
- Assist the MRO in reviewing of all participant’s signed informed consents once they are delivered to the Regulatory office and maintain a confidential tracking log for all IC’s across studies.
- Responsible for tracking of all research regulatory documents e.g. Staff HSP/GC training and practising licenses.
- Ensure centralized master files filling system is in accordance with GCP guidelines
- Ensure the functionality of the Regulatory affairs system (RAIS) including keeping it updated at all times
Assist in ensuring the functionality of Scientific review committee including organizing or scheduling its meetings
Required Qualifications, skills and experience.
- Good Clinical Practice (GCP) and Human Subjects Protection (HSP) certificates
- Bachelor’s degree in a health-related field (preferably Biomedical Sciences)
- Good knowledge of national and international research ethics guidelines
- Experience of working in a research setting
How to apply;
IDI will offer a competitive remuneration package to the successful candidate. Candidates that know that they meet the above criteria and have what it takes to excel in the above position, please send their CVs, which should include details of an email address (if any), present position, current remuneration, Certificate/testimonials and address of three (3) Referees plus telephone contact to the stipulated email address.
Please Email your application and CV to firstname.lastname@example.org and let’s save the environment.
Address your applications to;
The Senior Human Resource Manager
Infectious Diseases Institute — IDI Knowledge Centre, Makerere University Main
Campus; College of Health Sciences, Makerere University,
P.O. Box 22418, Kampala, Uganda
1. IDI is an equal opportunity employer and does not charge a recruitment fee or any other fees at any stage of the recruitment process
2. Internal candidates who meet the required specifications and have worked with IDI for a period of at least one year will be given priority.
3. Make sure that your application letter, CV and certificates are attached as one document
4. Indicate the Vacancy Code as the subject for your email
5. Only shortlisted candidates will be contacted
6. Any form of canvassing will lead to automatic disqualification.
Deadline: 25th June 2019.