Clinical Research Assistant

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Incumbent, with supervision/direction from the manager will serve as the research assistant for a variety of clinical trials and/or studies. The major purpose of this position is to provide support to the clinical trials coordinator(s) 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. High school diploma or equivalent AND two (2) years clinical research experience.

2. Phlebotomy Certification required after one (1) year

3. Clinical Research Coordinator Required after two (2) years

PREFERRED QUALIFICATIONS:

EDUCATION, CERTIFICATION, AND/OR LICENSURE:

1. Current Certified Ophthalmic Assistant (COA) certification

2. Current Certified Ophthalmic Technician (COT) certification

3. Certified Ophthalmic Medical Technologist (COMT) certification

EXPERIENCE:

1. One year of clinical or basic science 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 ensure 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. Assists Clinical Trials Coordinator with the conduct of clinical research studies under the supervision of a principal investigator.

4. Participates in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data.

5. Assists in gathering documentation of patient visits and assessments according to protocol.

6. Demonstrates competency in technical and clinical skills, completes skills, and correctly performs these skills daily as required.

7. Administers medications by all acceptable routes, as ordered by the physician and according to accepted policy and procedure

8. Completely and accurately transcribes and carries out physician orders.

9. Performs filing and data entry as needed to keep all research records and regulatory files up to date.

• Draw labs for Genetic Testing

10. Carries out ophthalmic testing and assessments as required by protocol and as assigned by designated investigator.

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

12. 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.

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

14. Ensures compliance with WVU Institutional Review Board, Good Clinical Practice (GCP Training) guidelines and federal regulations related to clinical research. Collaborative Institutional Training Initiative (CITI Training). ONCORE Training.

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

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

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

18. Associated clerical duties as ass