Protocol Management
•Assist in the establishment, and coordinates the implementation, of clinical research protocol priorities and organization structure.
• Prepares and updates SOPs for administration, clinical and data management activities within the Clinical Research Centers
• Review laboratory and clinic procedures and evaluations regularly that they meet protocol compliance.
• Coordinate the activation and maintenance of clinical protocols, including review and completion of submissions, amendments, and adverse event reports as required by the UIC Institutional Review Board (IRB), Protocol Review Committee and grant sponsors.
• Notify and inform clinical faculty/clinical dental providers, clinical staff, affiliates and grant sponsors of adverse events and protocol modifications, including their impact on the clinical research.
• Act as liaison between clinical faculty/clinical dental providers, clinical staff and the UIC IRB office, grant sponsors and regulatory agencies to ensure priorities are clearly communicated and resources are allocated appropriately across multiple ongoing projects.
Participant Enrollment and Protocol Compliance
• Assist investigators and clinical staff in identification, recruitment and enrollment strategies of patients to increase enrollment and to meet clinical research protocols.
Coordinate outreach to and liaison with staff at schools, community clinics, science fairs, etc. to make research presentations and recruit new clients for various research projects.
• Execute informed consent process and monitor patient status; Enroll clients into programs, explaining the research protocols to study participants and obtain appropriate consent forms. Ensure that enrollment and research activities comply with established protocols, regulatory and monitoring agency standards, and grant sponsor guidelines.
• Assist PI in creating CRF in REDCAP (or alternative electronic record).
• Assist in the clinical management of research activities including daily patient registrations, assisting in biological sample collection (blood draws, saliva samples, plaque and gingival curricular fluid, etc), assist in recording of data in CRF, and organizing the dental operatory for proscribed research-related procedures.
• Collect and reviews client evaluations/assessments, surveys, and participant interviews to develop reports for the PI and appropriate agencies and grant sponsors.
• Assist investigators in organizing study data for grant progress reports, analysis for meeting presentations, and publications.
• Perform other related duties and participate in special projects as assigned
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