Job no: 517368
Work type: Staff Full-Time
Location: Main Campus (Gainesville, FL)
Department:29090100 - MD-PEDS-ADMINISTRATION
Clinical Research Coordinator III
Manage assigned human subjects research studies including but not limited to:
Recruitment, review of inclusion/exclusion criteria, patient screening, facilitate informed consent, maintain accurate study records, collect data, update OnCore, coordinate communication for the study team, act as the liaison for the research participant, work collaboratively to ensure all study activities are completed, submit necessary compliance paperwork, and work with startup team to perform study feasibility and site activation;
Regulatory compliance management:
Activities include but are not limited to: initiating and maintaining a current regulatory binder; maintaining patient binder(s), preparing and submitting study documents related to human subjects research to both internal (UF-IRB, UF-CTC office, UF-IBC, OCR, etc) and external (FDA, WIRB, other Central IRB or consortiums, etc.) organizations as required; completing end of study procedures; scheduling and participating monitoring visits; 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; attending UF-IRB 01 full board meetings as necessary.
Activities include but are not limited to: perform literature reviews; work with study team to create and submit protocols; create and maintain databases, collect data and prepare for analysis, analyze data as needed; mentor other study coordinators or student research assistants as needed; assist with the development of patient programs and/or materials; create education materials as needed; assist with creation and development of grants; work collaboratively as part of a research team; maintain consistent communication and maintain project deadlines
Activities include but are not limited to: completing tasks as assigned to complete human subjects research; Satisfy annual competencies as required by the University of Florida and Institutional Review boards; participating in professional development and continuing education; provide mentorship regarding human subjects research as requested
$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, Ph.D., RN or similar credential in a health related field
- Knowledge and experience with clinical trial research process and policies
- Minimum 5 years experience in human subjects research
- Knowledge of UF policies and procedures around human subjects research
- Minimum 5 years clinical/direct patient contact experience
- Clinical Research Professional Certification (CRPC) or able to qualify for CRPC
- Good Clinical Practice (GCP) and IATA certified
- Experience using OnCore and Epic
- Experience working in a clinical setting
- Experience working within UF’s clinical research system
- Experience working in REDCap
- Experience working in Electronic Data Capture (EDC) systems
- Able to work collaboratively, forward ideas as appropriate and problem solve when needed.
- Multi-media capabilities strongly preferred; proficiency with Microsoft Office such as Word, PowerPoint and Excel.
Special Instructions to Applicants:
To be considered for this position, applicants must upload a cover letter or letter of interest, curriculum vitae or resume and a list of 3 professional references.
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 is hiring for multiple positions.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Health Assessment Required:Yes
Advertised: 13 Jul 2021 Eastern Daylight Time
Applications close: 27 Jul 2021 Eastern Daylight Time