| Job Description: |
Clinical Research Coordinator II will coordinate assigned clinical trials. The individual will work 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: 1. Ensuring regulatory compliance; 2. Serving as the study coordinator for assigned clinical trials; 3. Communicating with families participating in the study via telephone and in person to gather necessary research information; 4. Processing Human Subject Payments, when applicable; 5. Preparing and compiling necessary items for research study appointments.
Study Start-Up:
Responsible for start-up activities. Work closely with the PI, study team and Pediatrics Grants Office to obtain necessary external and internal paperwork for the 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 the 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) as well as the Division of Sponsored Research. Conduct a review of sponsor budgets for each clinical trial and work closely with the Pediatrics Grants Office during the budget negotiation to ensure that 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, serious adverse events. Maintain all OnCore requirements. Maintain up to date regulatory study binders. Provide sponsors with updated Regulatory documents. Maintaining a knowledge base of Good Clinical Practice regarding clinical trials, maintaining HIPAA compliance for assigned studies, communicating with interdisciplinary health teams in the care of patients involved in Pediatric Genetic Studies to ensure regulatory compliance. Reviews and develops a familiarity with the protocol, study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections. Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log. Establishes and organizes study files, including but not limited to, regulatory binders, case report forms, study specific source documentation.
Coordination of Subject Recruitment, Subject Visits, and Subject Data Collection:
Sole advocate/liaison for the Pediatric Genetic Research protocols for recruitment. Primary coordinator responsible for obtaining all informed consents for participants. Primary patient educator for the patient/participants for the Pediatric Genetic Protocols. Work with faculty and clinical staff in the division to review medical records of patients and identify potential research study participants. Utilize paper and electronic medical records and 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. Provide and gather informed consent from research subjects for assigned protocols. Ensure that subjects have a complete understanding of the consent before signatures are obtained. Develop referral mechanisms; maintain and develop relationships with referring physicians inside and outside of the institution for recruitment of study patients. Maintain regular periodic correspondence with physicians through written means such as handouts or newsletter. Obtain shipping certification and ship study labs per protocol requirements. Maintaining weekly contact with study participants as required per protocol. Prepare and ship central lab samples per protocol. Review of inclusion/exclusion criteria, patient screening, facilitate informed consent, maintain accurate study records, collect data, update OnCore, coordinate communication for the study team, act as the liaison for the research participant and work collaboratively to ensure all study activities are completed. Coordinates participant tests and procedures. Collects data as required by the protocol. Assures timely completion of Case Report Forms. Maintains study timelines. Maintains adequate inventory of study supplies. Completes study documentation and maintains study files in accordance with sponsor requirements. Retains all study records in accordance with sponsor requirements and university policies and procedures. Registers 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. Sole point of contact for current studies and new studies. Primary liaison between physician, pharmacists and nursing staff. Responsible for all coordination of subject visits. Responsible for all clinic scheduling of subject, PI, Clinical Research Center, IDS Pharmacy. Sole coordinator for the participants/subject’s pharmaceutical needs. Responsible for study drug assignments in sponsor system, responsible for patient EPIC order. Point of contact for study monitors, for scheduling, resolution of data base queries. Responsible for all patient related payments per protocol. Responsible for ensuring the processing of all human subject payments to all study subjects.
Prepare and compile necessary items for research study appointment and assist with administration of patient questionnaires and patient exams. Prepare and compile necessary items for research study appointment such as participant’ schedule, data collection forms, etc. Work with labs and clinics scheduling 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. Participate in all site initiation visits. Provide information about site and PIs access to institutional resources.
Data Management and Compliance:
Responsible for ensuring 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 that all data is entered correctly into the databases and is completed in a timely manner. Respond to queries from monitors. Works with monitors during site visits. Responsible for the general financial oversight of the Program ensuring that the 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 investigator and monitors to resolve case report form queries. Create study reference materials and other tools to ensure that all data is collected per protocol. Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms. Retains all study records in accordance with sponsor requirements and University policies and procedures. Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol management. Assists the PI in study feasibility assessments as requested.
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