Clinical Research Coordinator II - Pediatric Research Hub

Clinical Research Coordinator II

The Pediatric Research Hub and Obstetrics and Gynecology department is seeking an enthusiastic and qualified individual to fill a Clinical Research Coordinator II role focused on Multi-site engagement and program development for an important research study aimed at improving health care quality, outcomes and well-being for pregnant and postpartum women. This position will work closely with Dr. Kay Roussos-Ross (PI) and other study team members to develop, implement, and coordinate related projects. The coordinator will collaborate with internal and external research partners, clinical providers and other community stakeholders. Strong communication skills, the ability to work independently, and high motivation to deliver quality work products are a must. The ideal candidate will have human subjects research experience, project management experience excellent interpersonal skills, have experience with maternal/child health, and have experience working on grant funded projects.

Overall project management, external site engagement, and quality improvement work with Dr. Kay Roussos-Ross and other Investigators to develop relationships with external stakeholders and execute study needs. Oversee program development and implementation. Create and/or oversee creation of education materials for external partners related to project. Perform ongoing program evaluation. Responsible for managing all aspects of assigned projects aimed at improving health care quality, outcomes and well-being for pregnant and postpartum women. Create and implement communication plans and project specific training and study manuals. Organize team meetings to discuss projects, production of presentation materials to encapsulate current research and present future research options.

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, perform detailed chart review, 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.

Research Development:

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, mentor other study staff or student research assistants as needed; assist with the development of patient programs and/or materials; create education materials as needed for study staff and participants; may assist with creation and development of grants and study budgets; work collaboratively as part of a research team; maintain consistent communication and maintain project deadlines.

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-Institutional Review Board, UF-Institutional Biosafety Committee, Office of Clinical Research, etc.) and external (FDA, Department of Health Central IRB or consortiums, etc.) organizations as required; completing end of study procedures; scheduling and participating in monitoring or auditing 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. Work with key administrative personnel to prepare and submit compliance paperwork as needed.

Miscellaneous Activities:

Include but are not limited to: completing tasks as assigned to complete human subjects research; participating in professional development and continuing education; provide mentorship regarding human subjects research as requested; satisfying annual competencies as required by the University of Florida and Institutional Review Boards.

$55,000.00

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

• Knowledge and experience with clinical trial research process and policies
• Minimum 2-3 years experience in human subjects research
• Knowledge of UF policies and procedures around human subjects research
• Minimum 2-3 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.

In order to be considered, you must upload your cover letter and resume.

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