Study Coordinator

• Deadline: Expired

Job Summary

The study coordinator provides broad operational support for the HIP-CY study, including but not limited to the planning, scheduling, and overseeing the conduct of all day-to-day study activities to ensure high quality, effective and efficient productivity. The HIP-CY study applies implementation science to understand and design stakeholder informed innovative interventions to improve youth prevention and care continuums in rural and urban Uganda.

Overall Responsibilities

1. Prepare and monitor the implementation of study plan.
2. a) Develop and update study work plan.
3. b) Provides frequent and precise updates to the Investigators in an organized timely manner.
4. c) Track different study timelines, from study initiation to closeout.
5. Development of study materials and tools for the study.
6. a) Develop study source forms and SOPs.
7. b) Coordinate training of staff on study source forms and SOPs
8. c) Orient and coordinate appropriate training of new study staff.
9. Coordinate the ICF process development and consenting participants.
10. a) Develop the ICFs and related forms from the study protocol templates with guidance and review of the study PIs.
11. b) Track the ICF development process.
12. c) Ensures QC processes of the translated and original ICFs.
13. d) Support process of completed ICFs submission to the regulatory team.
14. e) Ensures staff training following approval on the ICFs.
15. Assists in the submission of appropriate study documents to appropriate IRBs and other regulatory bodies.
16. a) Support process protocols, investigator brochures and related documents for submission.
17. b) Track and carry out QC process of the investigator tools/ documents provided to the different stakeholders for review before submission to the regulatory institution.
18. Reviews study documents and case report forms for accuracy and appropriateness.
19. a) Ensure that tests, examinations, and procedures are properly performed, recorded, and reported.
20. b) Reviews study documents and case reporting forms for accuracy, completeness, and appropriateness
21. c) Follow up on staff response to queries/ citation following QC review, share QC reports.
22. Prepare and respond to any audit/ inspection/ monitoring/ internal quality assurance findings and implement approved recommendations.
23. a) Plan and prepare for regular study monitoring/audit/inspection visits.
24. b) Track and ensure full response to any monitoring/audit/inspection findings.
25. c) Liaise with various study staff in correcting issues raised from review.
26. Maintains effective and ongoing communication with sponsor, research participants, staff, and PI during the course of the study.
27. a) Provides frequent, timely and precise updates to the investigators and study staff.
28. b) Respond to required email communications in a timely manner.
29. c) Attend required conference call/ stakeholders’ meetings and share study updates as required.

Required Qualification, Experience and Competencies:

• Bachelor Science in Nursing or an equivalent health degree.
• At least 2 years’ experience in research conduct.
• 2 Years Relevant Experience

• Click to apply