Position Summary
The Clinical Research Coordinator manages and directs the coordination and timely handling of all components of clinical research protocols in and outside of the clinical setting. This position will develop and implement standards for research protocol management, policies, and procedures. Responsible for the implementation and conduct of multiple research projects. Coordinates comprehensive patient protocol treatment schedules to maintain compliance to protocol requirements. Develops and implements effective patient recruitment strategies, research budgets, and related fiscal planning
Duties & Responsibilities
- RESEARCH, Clinical Trials, DATA & PROTOCOL MANAGEMENT
- Lead within the department to improve clinical research practices and operations across studies and serve as a resource to others.
- Oversee and participate in coordinating and conducting complex clinical research studies, ensuring compliance with federal and institutional regulations.
- Take initiative in establishing and coordinating the implementation of clinical research protocol priorities and organizational structure based on study needs, identifying areas for improvement.
- Execute project goals and tasks as outlined in the project plan by actively assuming responsibility for components necessary for timely completion.
- Lead protocol changes, assessing and coordinating with various departments to implement changes.
- 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.
- Execute informed consent process and monitors patient status; Enroll participants into programs, explaining the research protocols to the clients and supporting family/friends, and obtain appropriate consent forms.
- Maintain working knowledge of current protocols and internal Standard Operating Procedures (SOPs) and disseminate information on any changes to all stakeholders.
- Collaborate with the Principal Investigator (PI), department, sponsor, and institution to support and guide the administration of compliance, financial, personnel, and other related aspects of clinical studies.
- Prepare, submit, and assist Investigators with multiple levels of research documentation, including educational materials, reports, grant renewal reports, and study forms.
- Prepare and evaluate protocols, manuscripts, reports, and dissemination tools.
- Lead team efforts in collaboration with the Assistant Director of Compliance to complete all activities and ensure regulatory compliance, including leading on all Protocol Deviations (PDs), Adverse Events (AEs), and Notes to File (NTFs).
- Collaborate with other research personnel with reports to regulatory agencies such as the IRB, FDA, and Data and Safety Review Committee.
- Ensure validity of research results through timely, accurate, and complete data submission, query resolution, and reporting of deviations.
- Solve complex problems related to data management and the analysis of large administrative datasets.
- Independently develop, manage, and report on key data, ensuring timeliness of data and reporting submissions from multiple investigators.
- Develop and implement procedures, maintain records, track progress, and conduct quality assurance on collected data.
- Actively collaborate with research call center agents to support efficient scheduling of research participants.
- Delegate tasks to team members within the study program.