Based on specific research program needs, patient facing vs. data administrative responsibilities will vary. Coordinates all clinical research activities with moderate supervision. This role will work within our neuromuscular research program with medically complex rare disease populations.
1. Conducts study start-up activities and prepares and maintains all regulatory documents required by sponsor and/or regulatory agencies.
2. Prepares protocols, informed consent documents, modifications, renewals and other necessary documents for review by the IRB and/or sponsor.
3. Coordinates study conduct with other departments to effectively implement clinical research projects; obtains required letters of support and/or approvals as needed (i.e. IBC, SRC, etc.) and protocol is followed.
4. Identifies and recruits eligible study subjects; conducts informed consent/assent process.
5. Arranges and conducts clinical research visits.
6. Conducts site qualifications, study initiation, monitoring and/or close-out visits.
7. Attends investigator meetings.
8. Abstracts data from medical records and enters medical information/data onto protocol specific case report forms, study flow sheets, and other required study forms; prepares abstracted/coded data for processing/analysis.
9. Creates and/or updates case report forms and/or source document templates.
10. Coordinates reimbursement of subjects.
11. Maintains inventory of supplies/equipment.
12. Prepares lab kits and requisitions prior to visits.
13. Collects specimens from subjects and processes specimens or works with Research lab to ensure samples are processed/sent out correctly.
14. Records data on source documents and CRF's and/or electronic web based systems.
15. Conducts literature searches and assists with QA/QC procedures.
16. Monitors/assesses adverse events and reports them as required.
17. Adheres to research protocol in compliance with applicable institutional, local and federal regulations (OHRP, FDA, GCP, etc.).
18. Functions as patient liaison for study questions, billing issues, etc.
19. Maintains all study documents (regulatory binders, source documents, correspondence, etc.).
20. Promotes the ethical conduct of research by actively participating in research related educational meetings/conferences (planning, presenting, etc.).
21. Performs job functions adhering to service principles with customer service focus of innovation, service excellence and teamwork to provide the highest quality care and service to our patients.
22. QA/QC checks for database validity and data monitoring.
23. Tracking deadlines for grants/deliverables.
1. High School Diploma with three to five years research experience -or- Associates /two years of College with two to four years research experience -or- Bachelors with one to three years research experience.
2. Knowledge of research regulations (FDA, OHRP, GCP, etc.) preferred.
3. Good clinical practices documentation required.
4. Familiarity and experience with FDA and IRB regulatory requirements preferred.