Clinical Research Coordinator III - Pediatric Endocrinology

University of Florida•Gainesville, FL

1d•Onsite

About The Position

The Department of Pediatrics at the University of Florida is seeking a qualified and enthusiastic individual to coordinate research for multiple projects related to Type 1 Diabetes. This individual will work in a team setting and under the supervision of the Principal Investigators. Job duties include functioning independently in a clinical research setting and being responsible for the complete coordination of assigned clinical research activities including fiscal, regulatory and auditing duties. Will have supervisory responsibilities. Employee will be responsible for coordinating project planning, recruiting study participants, collecting data, and assisting with written reports and presentations related to the project. This individual will communicate with faculty and staff as well as other internal and external constituencies. Ability to multi-task working as part of a team or independently.

Requirements

Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.
Proficiency with Word, Excel, SPSS or other statistical software, Web navigation tools and programs, and general computer functioning.
Strong written and verbal communication.
IRB/Regulatory experience and strong working knowledge of UF's Human Subjects Payments (HSP) protocols.
Ability to work independently.
Ability to collaborate with faculty and staff at multiple levels.

Nice To Haves

Knowledge of type 1 diabetes management and type 1 diabetes technologies (e.g., CGM and Pump).
Knowledge about Type 1 Diabetes including pump and CGM.

Responsibilities

Screening, recruiting, and enrolling patients/participants.
Educating subjects and family on protocols, study intervention, etc.
Developing and conducting of study billing plans.
Developing Informed Consent Forms (ICFs) and maintaining all reporting for ceded IRB processes.
Coordinating provider and patient-related recruitment and communications under the supervision of Principal Investigators.
Data entry of findings and results into data capture instruments and tables.
Managing several Phase I-III Pharma and NIH sponsored IND and IDE protocols.
Initiating contract negotiations with sponsors.
Tracking investigational product.
Serving as a liaison between the clinical team and the research team for research related patient visits.
Coordinating multi-center studies.
Assessing study feasibility and methodology for study initiation.
Assisting the investigator with grading and assessing adverse events and protocol deviations.
Monitoring/coordinating project planning, timelines, and tasks.
Coordinating scheduling for conference calls with all sites.
Preparing IRB/CRC/OCR documents and maintaining regulatory compliance.
Negotiating budgets for pharma trials and acting as liaison between the sponsor and UF’s OCR budget negotiation department.
Supervising reimbursement processes.
Attending trainings and all administrative meetings for the research teams.
Completing FDA IND/IDE paperwork for drug studies.
Creating and performing in-services for ancillary study location staff.
Assessing and bucketing EPIC charges and working with ancillary departments to ensure charges are credited to the correct projects.
Developing advertisement materials, informed consent documents, and case report forms.
Acting as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals.
Supervising work study students and training for research coordinator I personnel.
Educating staff on research policies and procedures, preparing staff for sponsor and FDA audits/monitoring visits/site initiation visits.
Assisting clinical staff in ensuring clinic efficiency in order to allow research to continue in parallel with clinical practice.