Job no: 517046
Work type: Staff Full-Time
Location: Main Campus (Gainesville, FL)
Categories: Agriculture/Life Science/Vet Medicine, Health Profession, Library/Physical/Social Science, Research/Scientific/Grants
Department:29090100 - MD-PEDS-ADMINISTRATION

Clinical Research Coord III

As part of the Pediatrics Research Hub, the Clinical Research Coordinator III will coordinate assigned clinical trials and assist with the Principal Investigator by communicating with families participating in the study via telephone and in person to gather necessary research information, provide informed consent, and address questions and concerns. Will also Prepare and compile necessary items for research study appointment and assisting with administration of patient questionnaires and patient exams. Will assist Principal Investigator in writing manuscripts, presentations, grants and IRB protocols and assist in data collection, compilation, and analysis for special projects, publications, etc.

Serve as study coordinator for clinical trial protocols as assigned - Activities include and are not limited to:

1. Recruiting patients to enroll in study(ies).
2. Coordinating patient visits.
3. Managing patient visits in accordance to protocol.
4. Coordinating site monitor visits.
5. Submitting necessary compliance paperwork.
6. Ensuring billing compliance.
7. Resolving issues/questions with sponsor.
8. Serving as the liaison between the Principal Investigator and study subjects.
9. Perform study feasibility.

Clinical trial regulatory compliance management - Activities included but are not limited to:

1. Initiating and maintaining a current regulatory file.
2. Preparing and submitting documents related to clinical trials to both internal (UF-IRB, UF-CTC office, UF-IBC, etc) and external (FDA, RAC, WIRB, etc) organizations as required.
3. Completing end of study procedures.
4. Schedule and participate in sponsored research monitoring visits.
5. Assuring that the integrity and quality of the clinical research trial is maintained and that the trial is conducted in accordance with Good Clinical Practice guidelines.
6. Attending UF-IRB 01 full board meetings as necessary.

Additional activities included but are not limited to:

1. Completing tasks as assigned to complete clinical trial(s).
2. Satisfying annual competencies as required by the University of Florida and Institutional Review boards.
3. Participating in professional development and continuing education.

Regular work schedule: 8:00 a.m. – 5:00 p.m, Monday - Friday. Variations from this schedule may exist due to:

$55,000 - $70,000 annually; commensurate within this range based on qualifications and experience.

Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.

• Master’s degree
• Registered Nurse (RN) License
• Knowledge and experience with clinical trial research process and policies
• Proficiency in all Microsoft Office applications; ability to communicate effectively both verbally and in writing
  Excellent interpersonal skills; ability to work independently, solve problems and make appropriate decisions
  Knowledge of UF and College of Medicine policies and procedures
• Prior experience of direct patient contact

Please upload a copy of your cover letter, resume/CV, and a list of three professional references with application.

The University of Florida is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.

This is a time-limited position.

This requisition has been reposted. Previous applicants are still under consideration and need not apply.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.

Yes

Advertised: 23 Jun 2021 Eastern Daylight Time
Applications close: 26 Jun 2021 Eastern Daylight Time