Visiting Senior Clinical Research Coordinator - Dept of Medicine, Division of Breathe Chicago Center

General Job Summary: The Visiting Senior Clinical Research Coordinator collaborates with the Principal Investigator and other team members to provide oversight, facilitation, and coordination of one or more research studies. This role is responsible for managing all phases of study implementation, from startup through close-out, while maintaining both day-to-day operational oversight and a broad overview of the project's status. The incumbent serves as the primary liaison for the project team, which may include physicians, nurses, project managers, lab technicians, and data staff; and communicates with internal and external hubs, sponsors, national groups and other external entities. Senior Clinical Research Coordinators are responsible for recruiting and retaining participants; developing and implementing SOPs, workflows, and protocol training; allocating staff time and tasks; reviewing data for accuracy; and achieving recruitment and visit completion targets to ensure study objectives are met.

Protocol Implementation and Management: In collaboration with the PI, oversee and manage the completion of goals and tasks as outlined in the project plan. Responsible for the implementation and ensuring the timely completion of all research activities. Track progress against milestones and project plans, and update plans as needed to meet project goals. Lead and manage the implementation of the research protocol, including developing, updating, and executing MOPs and SOPs, and ensure study staff are trained on all protocols and procedures. Serve as the on-site subject matter expert for all assessments and tests included in the protocol. Coordinate participant treatment schedules to maintain compliance with protocol requirements. Oversee and manage participant visits, ensuring that visits occur within the study window.

Data and Reporting: Ensure accuracy and completeness of data entry into the appropriate system within required study timelines. Accurately extract data from complex medical records. Collaborate with data analytics staff to set priorities and schedules for regular data auditing and cleaning. Develop reports for the study team and appropriate agencies.

Participant Recruitment and Retention: Lead outreach efforts and serve as a liaison at community events. Develop and deliver presentations to recruit participants. Develop and implement strategies to optimize the recruitment of research participants. Assist physicians and clinical staff in identifying prospective participants. Oversee participant screening and scheduling. Manage and oversee participant engagement activities, for example: communications, participant payments, navigating campus, etc. Analyze retention rates and develop retention plans.

Informed Consent and Regulatory Requirements: Coordinate the activation and maintenance of clinical protocols, including preparation and submission of applications, amendments, and adverse event reports as required by the UIC Institutional Review Board (IRB), Protocol Review Committee, and sponsors. Review study procedures and evaluations regularly to ensure protocol compliance. Oversee the study's informed consent process and manage participant status. Responsible for participant enrollment and for ensuring the study team communicates research protocols effectively to participants, their families, and support persons, and that all required consent forms are obtained and completed. Maintain detailed records of results and prepare written reports, including vitals and measurements; document and report adverse events as required. Collaborate with regulatory staff to ensure adverse events and protocol deviations are appropriately reported and documented. Other related duties Mentor junior staff and share best practices. Present study progress internally and/or at conferences. Participate in special projects as assigned.

Minimum Requirements: Bachelor's degree in nursing, mental health, psychology, pharmaceutical sciences, social science, or a related field required. A minimum of five years of experience conducting human participant research, or three years plus a master's degree in a relevant field required. Experience in a clinical research setting, experience working with Federal Regulations and IRBs required. Experience developing, managing, and implementing MOPs and SOPs for research protocols. Highly developed communication skills, including written, verbal, presentation, and interpersonal communication. Knowledge of: research protocols, principles, and procedures; aspects of clinical trials such as screening, interviewing, case report forms; experimental design, mathematics, statistics, computer applications and computer data management; a science such as biology or psychology; clinical tasks required for research (e.g. phlebotomy, centrifugation, interviewing); ethics and regulatory procedures in clinical trials (i.e. informed consent, IRB applications, data safety and monitoring plans). Experience with human subjects' research data management applications and scheduling systems. Ability to identify, produce, organize, evaluate, and interpret data. Ability to manage multiple tasks and deadlines. Ability to lead a project team.

Preferred Qualifications: Master's degree in a relevant field. Experience coordinating industry-sponsored clinical trials. Experience supervising and training research staff. Experience conducting research in underrepresented communities. Excellent organizational skills, including proficiency with email, web messaging, and calendar tools, and the ability to create and manage cloud-based documents. Certified Clinical Research Coordinator (CCRC), ACRP, or SOCRA certification preferred. Ability to work in a dynamic environment with shifting priorities. Strong time management and multitasking abilities. Prior experience with medical terminology and procedures, including electronic medical records and billing.

Working Conditions: This is a fully on-site role. Regular travel is not expected but may occasionally be required for scheduled events. The position involves extended periods of sitting, as well as visual acuity, manual dexterity, and keyboard use.