Clinical Research Coord II

University of Florida; Gainesville (FL); On-site; USD 55,000 - 60,000; Full time

Job summary

University of Florida in Gainesville seeks a Clinical Research Coordinator II to advance human subjects research. You will coordinate studies, extract data from EMRs, and ensure IRB compliance, working with the PI and study team to meet deadlines.

Responsibilities include data entry, regulatory binder maintenance, and contributing to manuscripts, grants, and educational materials. A Bachelor's degree with 2 years of experience is required, with HIPAA and GCP familiarity preferred.

Qualifications

• Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
• Experience coordinating research studies and managing study records.
• HIPAA and Good Clinical Practice familiarity preferred.

Responsibilities

• Coordinate research studies with minimal supervision or as part of a team.
• Perform CRC core responsibilities including large-scale data extraction from EMRs, data entry, and IRB compliance.
• Maintain regulatory binders and patient binders; communicate with study staff and sponsor/government representatives; assist with monitor/auditor visits.
• Assist with writing, editing, and/or submitting IRBs for new projects and ensure IRB compliance for current projects.
• Satisfy annual competencies and assist with progress reports, manuscripts, grants, protocols and educational materials.

Education

Bachelor's degree or equivalent

Tools

Epic

Microsoft Word

Microsoft Excel

PowerPoint

Job description

At the University of Florida, we are a people of purpose. We're committed to challenging convention and ourselves. We see things not as they are, but as they could be. And we strive for a greater impact: one measured in people helped...

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

Job Description:

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.

$55,000-$60,000

Required Qualifications:

Qualifications refer to evidence-based or demonstrated knowledge, skills, abilities, and experiences required for the role. For TEAMS positions the required qualifications should reflect Classification Minimum Requirements. For Faculty roles, these qualifications may reflect college-specific requirements needed for success the role.

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

Preferred Qualifications

• 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.