Clinical Trial Coordinator - Martinsburg

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Incumbent, with supervision/direction from the clinic manager will serve as the coordinator for a variety of clinical trials and/or studies. The major purpose of this position is to provide active leadership and control of all assigned clinical trials and studies in which the department is participating. In addition, the incumbent will perform all usual and necessary diagnostic testing required by those clinical trials to the ability of their level of skills and/or certification. This position will require incumbent to recruit patients for assigned studies which will include chart searches, advertisement, referrals and other means as necessary and directed. Incumbent will work directly with Administrator in fiscal matters and with various internal physicians, external physicians, internal regulation agencies, external regulation agencies, and a variety of patients.

MINIMUM QUALIFICATIONS:

EDUCATION, CERTIFICATION, AND/OR LICENSURE:

1. Bachelor's degree.

PREFERRED QUALIFICATIONS:

EDUCATION, CERTIFICATION, AND/OR LICENSURE:

1. Bachelor's degree in Nursing.

2. Certification as a Certified Research Assistant/Coordinator.

3. Successful completion of a formal, one year CAAHEP approved training course.

4. Certification at the Certified Ophthalmic Assistant level (COA).

EXPERIENCE:

1. Three years research experience.

CORE DUTIES AND RESPONSIBILITIES: The statements described here are intended to describe the general nature of work being performed by people assigned to this position.  They are not intended to be constructed as an all-inclusive list of all responsibilities and duties.  Other duties may be assigned.

1. Classify and maintain all study records within the department to insure that records are in compliance with study guidelines, confidentiality guidelines (both corporate and/or federal).

2. Familiarize and become highly knowledgeable with all study/clinical trials protocols currently assigned to the department.

3. Coordinate and implement procedures to collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources; code, evaluate and interpret collected data and prepare appropriate documentation; obtain blood samples, cultures, tissues and other specimens for laboratory analysis per protocol.

4. Ensure compliance with protocol guidelines and requirements of regulatory agencies; identify problems and/or inconsistencies and Monitor patients' progress to include documentation and reporting of adverse events; recommend corrective action as appropriate.

5. Assures that all protocol-specific activities have been scheduled and/or completed.

6. Interact with scheduling personnel to insure that patients are properly scheduled for initial, return and terminal visits in compliance with study protocols.

7. Liaison with all principal investigators and agencies to insure patients enrolled in studies/trials are properly cared for and that there is 100% compliance with study protocols and/or IRB guidelines.

8. Maintains a good understanding of all elements related to screening and enrolling patients in clinical research studies that he/she is responsible for.

9. Work collaboratively with investigators and study coordinators for study-specific training and communication related to possible or already accrued study participants.

10. Offers general clinical trial and protocol specific information to staff, community, professionals and the public.

11. Determines the need for study-specific training for study team members, patients and/or family members regarding research study requirements to ensure that all relevant individuals adequately understand key elements of the study.

12. Independently participates in activities to increase knowledge base and performance.

13. Ensures compliance with WVU Institutional Review Board, Good Clinical Practice guidelines and federal regulations related to clinical research.

14. Maintains timely and accurate reports of adverse events and protocol deviations to assure proper IRB and/or sponsor notification.

15. Maintains all record of patient visits, compliance and schedules for all patients enrolled into all clinical trials/studies.

16. Maintains timely, study-specific documentation that reflects an accurate, complete, and legible record of study activities.

17.