Senior Clinical Research Coordinator

Position Summary The CCTS Senior Clinical Research Coordinator is responsible for managing, coordinating and implementing all components of clinical research protocols, including pre and post research activities, internal and external to the clinical setting. Responsible for the implementation and conducting of multiple, complex research projects in the Clinical Research Center. Manages comprehensive patient protocol treatment schedules to maintain compliance to study protocol requirements. Develops and implements effective patient recruitment strategies. Oversees all aspects of various multi-faceted investigations. Prepares IRB submissions, regulatory document preparation and collection.

Duties & Responsibilities

• Protocol Management
• Assist in establishing and coordinating the implementation of clinical research protocol priorities and organization structure.
• Train staff on research protocols and procedures.
• Extract data from complex medical records with expert accuracy.
• Notify and inform PI, physicians, clinical staff, affiliates and grant sponsors of adverse events and protocol modifications, including their impact on the clinical research program.
• 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.
• Review laboratory and clinical procedures and evaluations regularly to ensure protocol compliance.
• Act as liaison between physicians, 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.
• Communicate clinical information and work with stakeholders to create best practice tools.
• Client Enrollment and Protocol Compliance
• Assist PI, physicians and clinical staff in identification, recruitment and enrollment strategies of patients to increase enrollment and to meet clinical research protocols.
• Schedule and conduct clinical research visits required by the protocol and track participant visits.
• Schedule all patient examinations, repeat examinations, treatments and laboratory visits required by the protocol.
• 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.
• Screen patients for protocol eligibility and participation in clinical research.
• Complete patient assessment of anthropometrics and perform phlebotomy.
• Execute informed consent process and monitor patient status; Enroll clients into programs, explaining the research protocols to the clients and parents, and obtain appropriate consent forms.
• Ensure that client enrollment and research activities comply with established protocols, regulatory and monitoring agency standards, and grant sponsor guidelines.
• Conduct clinical, behavioral and observational surveys of clients and parents.
• Collect and review client evaluations/assessments, surveys, and participant interviews to develop reports for the PI and appropriate agencies and grant sponsors.
• Complete accurate, concise, and legible documentation of all participant records and other source documentation and forms per protocol, (i.e. maintain drug documentation, reconciling study drug accountability).
• Conduct basic lab duties including centrifuging, alloquoting, and storing and shipping of study specimens.
• Prepare study data for grant progress reports, analysis for meeting presentations, and publications.
• Participate in required clinical research education and training programs.
• Perform other related duties and participate in special projects as assigned.