Clinical Research Coordinator II
Classification Title: Clinical Research Coordinator II Job Description:
The Department of Aging and Geriatric Research is currently recruiting for a Clinical Research Coordinator II position to lead sponsored clinical trials for the Clinical Research Division. The duties will include:
Coordinate, participate in and perform day to day activities for specific research studies. Stay up-to-date with all training required and become knowledgeable in the protocols for assigned studies inventory. Conduct recruitment related activities including telephone screening and community recruitment initiative. Conduct study visits according to the study protocol. Obtain informed consents; collect medical history and medication information. Review pre-procedure (e.g., muscle and fat biopsy) checklists; provide and explain discharge and post-procedure instructions to research participants. Administer behavioral and psychological questionnaires. Work closely with study Principal Investigators to determine study participant eligibility. Follow-up with study medical director on any participant adverse events (AEs) and serious adverse events (SAEs). Issue documents as necessary, create and maintain the study documents in an organized manner; manage and enter study data. Maintain the required compliance and safety training paperwork.
May interact with institutional committees for safety of human subjects in research studies. Work closely with and assist the investigators with timely preparation and prompt submission of IRB, CRC, and internal routing forms for new and continued renewal of study related documents, and other regulatory protocols and documentation. Monitor compliance for all research activities and ensure that all aspects of the studies are conducted in accordance with the studies protocol and contract, and that all legal aspects adhere to state and federal regulations and guidelines. Ensure all study protocols are conducted in compliance with the requirements of the College of Medicine and the University of Florida, and that all requirements of the funding agency are met including auditing. Participate in Division and study-related meetings.
Collaborate with PIs in implementation of studies. Assist in protocol development, study operations, closing of studies and transitioning staff for new studies. Ensure the prompt submission of internal routing forms for new and continued renewal of study related documents. Review guidelines for requests for proposals and requests for applications to recruit and assist faculty applications. Participate in the reviews of submissions of protocols and grants sent to the Office of Research and provide follow-up as necessary.
Oversee the data quality control and data safety requirements; assist in the development of data collection forms, manuals of operations and procedures, as well as other documents required for project implementation and evaluation, such as computerized methods for monitoring and reporting on the study requirements.
Perform standard medical procedures and tests: take vital signs, draw blood, perform urine collections, may perform catheter setting and process blood samples. Perform electrocardiograms (ECG’s), physical performance measures (grip strength, SPPB, 400M walk, Biodex), and cardiovascular measures. Administer ultrasounds, prepare participants for biopsies, assist physicians with biopsies; assist with lab-related duties. Oral and written instructions and training are received from the division and department leadership. The incumbent is expected to seek out and request guidance as needed and should be actively involved in obtaining solutions and resolving issues that may arise. The incumbent is expected to complete work assignments independently with minimal instructions and supervision.
The incumbent will manage OPS interventionists and student assistants; may manage future TEAMS positions depending on the direction of the program.
The position may require occasional travel.
$45,000 - $50,000; commensurate education and experience
Pay Range Based on Market:
Lower reference point: $44,700 Midpoint: $58,100 Upper Reference point: $71,500
Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
- 3-9 years of relevant work experience and certifications are highly preferred.
- Excellent interpersonal skills and the ability to prioritize and effectively communicate verbally and in writing.
- Good knowledge of existing government pharmaceutical & clinical protocols.
- Ability to establish and maintain working relationships with University, College and administrative representatives
- Ability to prepare, produce and present reports
- Ability to deal effectively with the faculty, staff, and regulatory agencies
- Current certification of Human Subjects protection compliance
- Accreditation as Certified Clinical Research Coordination through ACRP preferred.
- CPR and BLS certification preferred. Experience with personal computer including word processing, spreadsheet and database software.
- This position has to have a superior ability to interact with research participants, and to build and maintain a good working relationship with the coworkers and collaborators.
- Ability to make quick and correct judgment calls, discern quickly the different aspects of the job and show flexibility in employing various approaches needed to resolve each situation.
In order to be considered, you must upload your cover letter and resume, and the contact information for three professional references.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Health Assessment Required: Yes