Oversees and coordinates individual studies on day-to-day basis.Demonstrates through behavior Huntsville Hospital’s mission, vision and values as outlined in this document, Employee Handbook and the Power of Excellence. Minimum Knowledge, Skills, Experience Required/Education: Graduate of an accredited school of nursing or bachelor’s degree in science or other health-related profession.
Experience: Minimum of two years in Patient Care. Clinical Research Coordinator experience preferred.
Additional Skills/Abilities: Certification as Clinical Research Coordinator (CCRC) is preferred.
Key Responsibilities / Essential Functions
1. Understand fully the research protocols for which lead coordinator duties have been assigned, and have a good working knowledge of research protocols for which backup coordinator duties have been assigned.
2 Participate in site selection and site initiation meetings as assigned.
4. Prepare for study initiation by creating flow sheets, logs, physician order forms, source documents and enrollment packets.
5. Recruit patients for participation in assigned research studies to meet or exceed enrollment goals, including seeking referrals from physicians and licensed personnel.
6. Screen potential study participants using study inclusion and exclusion criteria.
7. Explain to the patient/family the research study and the elements of the informed consent, and ensure signed consent is obtained prior to study procedures being performed
8. Educate patient/family regarding disease process and study protocol.
9. Schedule patients for assigned studies according to protocol specifications and windows.
10. Complete study visits and assessments according to FDA-approved study protocols.
11. Collect accurate data by maintaining accurate and thorough documentation, including source documents (clinic charts) and case report forms (CRFs), at each study visit. Ensure all paperwork is completed in a timely manner.
12. Assess patient’s condition and report any significant variations from baseline to the principal investigator or a sub-investigator. 13. Complete all queries in a timely manner.
14. Submit serious adverse event reports to sponsors and to the appropriate Institutional Review Boards (IRB), preparing all necessary documentation within required timelines. Provide data for annual reports to the IRB.
15. Receive, store and properly dispense all study medication, and maintain appropriate drug log documentation.
16. Assist in the obtaining and disposition of specimens, EKGs, holter monitors, echocardiograms, stress tests, nuclear scans, heart catheterizations and other assessments whenever applicable.
17. Educate physicians regarding study protocols and requirements, and seek referrals from them.
18. Educate extenders and nursing staff regarding study protocols, and respond to questions regarding studies and/or patients.
19. Rotate on call duty as scheduled. On call requires availability for performing study assessments after hours and on weekends, as well as consultation/ questions regarding studies, accessibility to study patient’s chart, contact with principal investigator or his designate, and other research staff if needed during non-office hours.
20. Meet with monitors and auditors on a regular basis during and after clinical trial participation. Ensure all changes and corrections arising from monitor visits and audits are completed in a timely manner.
21. Act as an ambassador for the Research Department and The Heart Center, PC with representatives from pharmaceutical sponsors and contract research organizations, and all external entities.
22. Submit accurate data for billing and computer tracking.
23. Receive and store study documents maintaining confidentiality.
24. Complete ongoing training as required by federal agencies, sponsors and the Research Department.
25. Attend weekly research department meetings.
26. Special duties as assigned by the Research Director.
Graduate of Accredited School of Nursing with current Alabama licensure. Clinical Research Coordinator experience preferred.
Huntsville Hospital, the second largest hospital in Alabama, is a 941-bed hospital that serves as the regional referral center for north Alabama and southern Tennessee. In recent years, the hospital has expanded its service throughout the region with the development of Huntsville Hospital Health System, making it the third largest publicly owned hospital system in the nation with more than 1,800 beds and 12,000 employees.