Clinical Research Coord II

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

About the Role

The Clinical Research Coordinator II will coordinate assigned clinical trials, working in a team setting under the supervision of the Principal Investigator. As the lead coordinator for Dr. Zori’s clinical research group, the incumbent will assist the Principal Investigator by performing the following activities on clinical trials with minimal supervision:

• Ensuring regulatory compliance;
• Serving as the study coordinator for assigned clinical trials;
• Communicating with families participating in the study via telephone and in person to gather necessary research information;
• Processing Human Subject Payments, when applicable;
• Preparing and compiling necessary items for research study appointments.

Responsibilities

Study Start-Up

• Work closely with the PI, study team, and Pediatrics Grants Office to obtain necessary external and internal paperwork for study review and approval, including but not limited to Informed Consent, protocol, Draft Budget and Contract, Confirmation of Services, Billing grids, and study initiation checklists.
• Prepare protocol submissions for IRB review, coordinating with sponsors as well as UF’s Institutional Review Board, UF’s Biosafety Committee, the Western Institutional Review Board, General Clinical Research Center (GCRC), and the Division of Sponsored Research.
• Conduct a review of sponsor budgets for each clinical trial and work closely with the Pediatrics Grants Office during budget negotiation to ensure costs for the study are covered.
• Submit all necessary compliance paperwork to the Office of Clinical Research.
• Submit accurate Institutional Review Board documents for new and ongoing studies, such as protocol amendments, continuing review, study closure reports, and serious adverse events.
• Maintain all OnCore requirements and up-to-date regulatory study binders.
• Provide sponsors with updated regulatory documents.
• Maintain a knowledge base of Good Clinical Practice regarding clinical trials, HIPAA compliance for assigned studies, and communicate with interdisciplinary health teams to ensure regulatory compliance.
• Review and develop familiarity with the protocol, study proceedings and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections.
• Assist PI in communicating study requirements to all individuals involved in the study and provide appropriate training and tools for study team members.
• Document training dates and signatures of study personnel on study-specific training logs.
• Establish and organize study files, including regulatory binders, case report forms, study-specific source documentation.

Coordination of Subject Recruitment, Visits, and Data Collection

• Serve as the sole advocate/liaison for Pediatric Genetic Research protocols for recruitment.
• Obtain all informed consents for participants and serve as the primary patient educator for the patient/participants for the Pediatric Genetic Protocols.
• Work with faculty and clinical staff to review medical records of patients and identify potential research study participants.
• Utilize paper and electronic medical records to contact potential research participants via mailings and telephone calls with the assistance of the Principal Investigator and genetic counselor.
• Communicate with families participating in the study via telephone and in person to gather necessary research information, provide informed consent, and address questions and concerns.
• Ensure subjects have a complete understanding of the consent before signatures are obtained.
• Develop referral mechanisms and maintain relationships with referring physicians inside and outside the institution for recruitment of study patients.
• Maintain regular periodic correspondence with physicians through written means such as handouts or newsletters.
• Obtain shipping certification and ship study labs per protocol requirements.
• Maintain weekly contact with study participants as required per protocol.
• Prepare and ship central lab samples per protocol.
• Review inclusion/exclusion criteria, facilitate patient screening, informed consent, maintain accurate study records, collect data, update OnCore, and coordinate communication for the study team.
• Act as the liaison for the research participant and ensure all study activities are completed.
• Coordinate participant tests and procedures, collect data as required by the protocol, and ensure timely completion of Case Report Forms.
• Maintain study timelines and adequate inventory of study supplies.
• Complete study documentation and maintain study files in accordance with sponsor requirements and university policies.
• Retain all study records in accordance with sponsor requirements and university policies.
• Register each participant in the billing matrix to ensure billing of study procedures to the appropriate funding source.

Technical Assistance in Project Administration

• Independently coordinate and oversee all aspects of the Pediatric Genetic Protocols.
• Serve as the sole point of contact for current and new studies.
• Act as the primary liaison between physician, pharmacists, and nursing staff.
• Coordinate all aspects of subject visits and clinic scheduling for subjects, PI, Clinical Research Center, and IDS Pharmacy.
• Serve as the sole coordinator for participants/subjects' pharmaceutical needs.
• Handle study drug assignments in the sponsor system and manage patient EPIC orders.
• Act as the point of contact for study monitors for scheduling and resolution of database queries.
• Ensure the processing of all human subject payments per protocol.
• Prepare and compile necessary items for research study appointments and assist with administration of patient questionnaires and exams.
• Work with labs and clinics to schedule trial patient visits.
• Schedule research study participants on the General Clinical Research Center (GCRC) and with any other necessary procedural offices.
• Assist Principal Investigator with patient transport.
• Provide study participant follow-up, facilitate daily team communication, and attend regular research team meetings.
• Create reminders, handouts, and checklists for patients.
• Participate in site selection calls and conferences, and all site initiation visits.
• Provide information about site and PIs access to institutional resources.

Data Management and Compliance

• Ensure regulatory compliance (WIRB, Billing, Study documentation, Electronic data capture, etc.).
• Collect and enter case data from source documents to sponsors’ paper and/or electronic case report forms and data management systems.
• Ensure all data is entered correctly into databases and completed in a timely manner.
• Respond to queries from monitors and work with monitors during site visits.
• Provide general financial oversight of the program to ensure studies are cost-effective, salaries are covered, and expenses are being paid.
• Advise PIs on hiring new personnel, capital equipment purchases, and other major expenses.
• Enter data on paper and electronic case report forms for each sponsor, collaborate with investigators and monitors to resolve case report form queries.
• Create study reference materials and other tools to ensure all data is collected per protocol.
• Complete study documentation and maintain study files in accordance with sponsor requirements and university policies, including consent forms, source documentation, narrative notes, case report forms, and investigational material accountability forms.
• Retain all study records in accordance with sponsor requirements and university policies.
• Work with the PI to manage the day-to-day activities of the study, including problem-solving, communication, and protocol management.
• Assist the PI in study feasibility assessments as requested.

Requirements

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

Qualifications

• Preferred Qualifications:
  • Medical office experience, including knowledge of CPT and ICD-10 coding guidelines.
  • Excellent written and verbal communication skills.
  • Excellent computer skills, including fluency in programs such as Microsoft Access and Excel.
  • Understanding of general medical terminology.
  • Knowledge of clinical trial flow.
  • Thorough knowledge of the regulatory and compliance process.

Pay

Expected salary: $55,000 - $60,000 annually; commensurate within this range based on qualifications and experience.

Schedule

Normal work hours are 8:00 AM to 5:00 PM, Monday through Friday.