Clinical Research Coord II
About The Position
Incumbent will coordinate research studies with minimal supervision or as part of an assigned team. Incumbent will perform all Clinical Research Coordinator (CRC) Core responsibilities as well as additional responsibilities detailed below for Clinical Research Coordinator II. Assignments for this position include large scale data extraction from electronic medical records, data entry, and IRB compliance. Incumbent will manage projects according to established deadlines, maintain accurate and timely records, maintain consistent communication and assist with the development of manuscripts, grants, protocols and educational materials as needed. Perform detailed chart review, review of inclusion/exclusion criteria, input data into Sponsor and/or internal database(s), resolve data queries in a timely fashion, and assist with data clean up and analysis on specific projects as needed. Maintain consistent communication at regular/frequent intervals with PI and study team, maintain regulatory binders and patient binders as applicable, maintain good working relationships with study staff and Sponsor/Government Agency representatives, assist with monitor/auditor visits, and assist with grant-required progress reports. Complete required trainings on protocols as directed, work on special projects as needed, conduct literature reviews, and create bibliographies as needed. Assist with writing, editing, and/or submitting IRBs for new projects and ensure IRB compliance for current projects. Miscellaneous Activities – Activities include but are not limited to: completing tasks assigned to complete human subjects research; Satisfying annual competencies as required by the University of Florida and Institutional Review boards; participating in professional development and continuing education.
Requirements
- Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
Nice To Haves
- 2-3 years experience reviewing medical record or clinical data preferred
- 1-2 years human subjects research experience preferred
- Experience applying the following regulations and guidelines: Good Clinical Practice Guidelines, Health Information and Accountability Act (HIPAA), Protection of Human Research Subjects
- Experience using Epic preferred
- Experience working in Electronic Data Capture (EDC) systems preferred
- 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.
Responsibilities
- Coordinate research studies with minimal supervision or as part of an assigned team.
- Perform all Clinical Research Coordinator (CRC) Core responsibilities as well as additional responsibilities detailed below for Clinical Research Coordinator II.
- Perform large scale data extraction from electronic medical records.
- Perform data entry.
- Ensure IRB compliance.
- Manage projects according to established deadlines.
- Maintain accurate and timely records.
- Maintain consistent communication.
- Assist with the development of manuscripts, grants, protocols and educational materials as needed.
- Perform detailed chart review.
- Review of inclusion/exclusion criteria.
- Input data into Sponsor and/or internal database(s).
- Resolve data queries in a timely fashion.
- Assist with data clean up and analysis on specific projects as needed.
- Maintain consistent communication at regular/frequent intervals with PI and study team.
- Maintain regulatory binders and patient binders as applicable.
- Maintain good working relationships with study staff and Sponsor/Government Agency representatives.
- Assist with monitor/auditor visits.
- Assist with grant-required progress reports.
- Complete required trainings on protocols as directed.
- Work on special projects as needed.
- Conduct literature reviews.
- Create bibliographies as needed.
- Assist with writing, editing, and/or submitting IRBs for new projects.
- Ensure IRB compliance for current projects.
- Complete tasks assigned to complete human subjects research.
- Satisfy annual competencies as required by the University of Florida and Institutional Review boards.
- Participate in professional development and continuing education.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
