Tropical Gastroenterology & Nutrition Ltd
Compliance Officer Job Description:
TROPICAL Gastroenterology & Nutrition Ltd (TROPGAN) is a non-governmental Organisation that was founded in 1999 to facilitate research into Tropical Gastroenterology and Nutrition and to find ways to enhance clinical care for adults and children with Gastroenterology Intestinal and Nutritional disorders. TROPGAN is searching for a motivated and experienced clinical research and compliance officer to guarantee that our organisation processes and transactions follow all relevant legal and internal guidelines. Your duties will include reviewing research protocol, developing case report forms (CRFs), and responding to policy violations.
The ideal candidate will be professional, highly-analytical, and possess excellent written and verbal communication skills. To prosper in this role, you should be fluent in risk management and our organisation’s principles.
Responsibilities:
1. Coordinates with Principal Investigator to help ensure that clinical research and related activities are performed in accordance with regulations and sponsoring agency policies and procedures
2. Assist the PI in developing materials tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan.
3. Ensure that all key personnel or persons engaged in the research project have met training requirements with regulations, university and sponsoring agency policies and procedures
4. Review and comprehends the protocol
5. Collaborate with the PI to prepare any other regulatory submission documents as required by the protocol
6. Prepare other study materials as requested by the PI. These study materials include, but not limited to the informed consent document, case report forms (CRFs), enrolment logs, and drug/device accountability logs
7. Establishes and organizes study files including but not limited to, regulatory binders, study specific source documentation and other materials
8. Works with the PI to manage the day-to-day activities of the study including problem solving communication and protocol management
9. Advise management on the company’s compliance with laws and regulations through detailed reports.
Requirements:
1. Bachelor’s degree in biomedical sciences, general nursing, or a related field.
2. Knowledge in quality assurance, first Aid and Laboratory instruments
3. Good clinical laboratory practice
4. Certified fire Marshall
5. Monitor and Evaluation Certificate
6. Knowledge of Working knowledge of health care laws and regulations.
7. 3 – 5 years’ proven experience in a compliance officer role.
Method of Application
Interested candidates should send their cover letter and CV’s to admini@tropgan.net not later than 28th May 2023.
Please Note:
1. Do not apply if you do not have any previous experience in clinical research and compliance work.
2. Candidates who are familiar with the UNZA RHinno and RHinno Ethics online platforms will have an added advantage.
3. Only shortlisted candidates will be contacted.