To implement clinical research and to insure compliance with clinical protocols, institutional regulations and federal (FDA) requirements; to ensure quality health care through careful monitoring of all patients and procedures; to support and conduct research for assigned study protocols under the direction of the Research Manager .
Plan, implement and monitor participant recruitment and retention procedures.
Interpret and implement
Prot ocol procedures and policy.
Screen and interview study participants
Maintain case report forms, charts and documentation.
Review lab and procedure results.
Dispense medication and maintain records
Perform procedures as needed.
Assists Division staff as needed.
Job related travel as necessary.
Other duties as assigned.
Coordinates recruitment and retention by in services. Demonstrates knowledge of study protocol/policy by following study guidelines with 98% accuracy. Continually establishes participant eligibility, documents appropriately and reports to manager. Appropriately documents with 98% accuracy and completion. Meets specified timelines. Refers abnormal lab or procedure results to MD or ARNP with appropriate follow-up. Appropriately dispenses and records study medications per FDA, Institutional and sponsor guidelines. Evaluates participant overall health and study eligibility by review of subjective/objective data. Assists with filing stocking of supplies, scheduling, answering phones, and Division staff as requested by supervisor. Travels to appropriate study meetings or community in services. Accepts responsibility for additional assignments or informs supervisor if unable to complete assignments.
SKILLS, QUALIFICATIONS, AND REQUIRED EXPERIENCE
Ability to perform phlebotomy
Knowledge of medical terminology
Understanding of clinical research process
Knowledge and application of approved Clinical Practices
Familiarity with the Code of Federal Regulations as they pertain to human subject clinical research
- Strong interpersonal skills
- Excellent communication and organizational skills
- Strong computer skills including database management and spreadsheets
- Strong calculations skills
- 2-5 years of nursing experience is preferred.
- Research experience preferred
Education and Certifications
High School graduate or GED equivalent required
- Florida licensed Registered Nurse or LPN preferred
University of Florida Jacksonville Healthcare Inc. - 16 months ago