1. Coordinates activation workflows to ensure appropriate timelines are met.
2. Execution of confidentiality agreement for all clinical trial opportunities
3. Assists in maintaining trial activation resources, brochures and start-up materials for activation process
4. Completes feasibility questionnaires for clinical trials presented to the Clinical Trials Office
5. Liaison with internal or external clients, sponsors, or partners for assigned studies, projects, or programs. Lead contact for all project matters; understand and manage contractual and organizational client expectations; nurture client relationship and needs. Provide to the sponsor regular reports on project status, certain metrics, and issues.
6. Manage project deliverables. Track progress by keeping close metrics, including but not limited to time and quality. Be accountable for follow-up on action items. Work with the Project Administrator and Manager in identifying, resolving, or escalating issues.
7. Represent the Clinical Trials Office in HCI Clinical Trial Research Group meetings
8. Complete intake Clinical Trial Research Group new study review and prioritization forms.
9. Submit trial packages to the Feasibility Administrative Review committee and follow-up on action items to achieve approval.
10. Liaise with the Office of Sponsored Projects and CTO Finance Pre-Award team to ensure appropriate and timely execution of CDAs, CTAs and study budgets. Assist in scheduling calls and supporting negotiations in these areas.
11. In cooperation with research managers and administrators, organize and actively participate in sponsor site visits.
12. Serve as an internal liaison to bridge trials from activation to start-up.
13. Act as a liaison between study sponsors, HCI investigators and the Clinical Trials Office by evaluating problems and providing solutions.
14. Understand and act within the framework of regulatory guidelines provided by federal, state, and local regulatory agencies and ethical guidelines pertaining to the conduct of clinical research.
15. Promote a positive work environment that is maintained through open and effective communication
16. Serve as first point of contact for potential outside CROs and sponsors. Be the face of the HCI CTO.
17. Establish and foster strong relationships and interactions with HCI investigators, study sponsors and the Clinical trials office personnel.
18. Ensure high quality of data and metrics to study sponsors and research teams.
19. Assist in process and efficiency improvements in the trial activation area.
20. Must be able to work independently and have strong communication and human relations skills.
This job description is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
Work Environment and Level of Frequency typically required
Nearly Continuously: Office environment.
Physical Requirements and Level of Frequency that may be required
Nearly Continuously: Sitting, hearing, listening, talking.
Often: Repetitive hand motion (such as typing), walking.
Seldom: Bending, reaching overhead.
