Summary of Position:
The Clinical Trials Coordinator provides leadership and guidance to the multidisciplinary research team. Responsibilities include overall management of all aspects of clinical trials including timelines and reporting. In this role the Clinical Trials Coordinator also ensures the alignment of the clinical research objectives with the Sault Area Hospital strategic objectives. The CRC works collaboratively with key leaders within the institution to integrate the research activities in their respective departments.
The Clinical Trials Coordinator ensures the successful implementation, execution and completion of research protocols – from study set-up to closeout. In this role the incumbent will coordinate and oversee clinical trials to ensure compliance with the study protocol, as well as ethical, regulatory and sponsor requirements, good clinical practices and standard operating procedures.
DUTIES:
1. Conduct a needs assessment for the clinical trial skill sets for each study
2. Responsible for building relationships with academic and industry partners to support and enhance clinical trials activities
3. Act as liaison between clinical trial site and sponsor representative
4. Develop and implement strategies to measure clinical trials productivity, including identification and measurement of key performance indicators
5. Facilitate conduct internal auditing and monitoring of clinical research to ensure accurate, complete collection of data including pharmacy documentation to ensure compliance with Good Clinical Practice guidelines
6. Facilitate external auditing of clinical research by regulatory bodies
7. Conduct and document informed consent discussion
8. Prepare clinical trials reports for both internal and external bodies
9. Prepare informed consent forms for sponsor and REB approval.
10. Develop tools or processes to organize and track clinical trial activities
11. Interact and correspond with investigator, site staff/departments, sponsor, monitors
12. Coordinate REB submissions and communications and ensure REB approvals are obtained for new protocols and annual IRB renewals
13. Attend protocol investigator meetings
14. Coordinate staff training on the protocol prior to study activation
15. Enroll eligible study subjects (register/randomize)
16. Monitor subject scheduling and protocol compliance
17. Ensure subject completion of study forms (QOL, diaries)
18. Provide patient education
19. Collect, process, store and ship study samples (ex. pharmacokinetics)
20. Data collection and source documentation
21. Complete adverse event and serious adverse event reports
22. Complete case report forms (CRFs)
23. Ensure that protocol amendments are appropriately distributed, communicated and approved
24. Review and update the Standard operating policies and procedures to ensure compliance with the regulatory guidelines
25. Develop and negotiate study budgets and contracts.
26. Oversee invoicing and payments for various studies.
QUALIFICATIONS:
1. Bachelor degree in a health related field (I took out equivalent because what would we consider equivalent to a bachelor’s degree)
2. Relevant clinical experience in therapeutic area involved preferred
3. Clinical Research Coordinator certification (SOCRA, ACRP) an asset
SKILLS & ABILITY:
1. Excellent oral and written communication skills
2. Must be organized with attention to detail
3. Ability to work independently
4. Communication of empathy, warmth and respect for subjects
5. Proficiency in drug therapy, drug management, drug accountability
6. Ability to write order sets for the administration of study drugs
7. Ability to work within multiple sponsor initiated portals ( SIP, My Trials, etc), Electronic case report form environments (Medidata RAVE, oracle, InForm etc)
8. Ability to complete mathematical calculations such as medication doses, BSA, BMI, AUC, Gfr etc
9. Blood processing skill sets
10. Ability to operate lab equipment
11. Maintains subject confidentiality
