Clinical Research Studies Manager

* Staff Management & Training.* Supervises, mentors, and trains clinical research coordinators and ensures the highest standards of study conduct while facilitating staff professional development.* Manages recruitment, selection, and onboarding of clinical research coordinators and research staff, ensuring thorough orientation and compliance with institutional standards.* Provides staff training on policies and procedures for Good Clinical Practice (GCP), 21 CFR Part 11 compliance, study conduct and regulatory documentation.* Mentors research coordinators throughout clinical study development phases, providing guidance from protocol development through study participant enrollment.* Addresses inquiries and provides guidance to research coordinators on study participants eligibility criteria for accuracy and compliance.* Ensures all staff and faculty involved in clinical studies have completed CITI and other regulatory trainings as mandated by IRB policies.* Regulatory Compliance & Documentation.* Conducts subject consent audits to verify adherence to ethical and regulatory standards.* Develops and reviews all IRB filings, clinical trial protocols and informed consent documents to ensure regulatory and ethical compliance.* Acts as departmental liaison with regulatory agencies (FDA), Institutional Review Board (IRB) and Clinical Trial officials.* Directly communicates with FDA officials to coordinate Investigational New Drug (IND) submissions and responses to regulatory queries.* Responsible for preparing, submitting, and maintaining all Institutional Review Board (IRB) documentation for research protocols, amendments, and annual reviews.* Develops departmental standard operating procedures (SOPs) to ensure consistent protocols and quality standards.* Clinical Trial Operations.* Manages day-to-day clinical research study operations for research staff and principal investigators (PIs).* Supports clinical trial initiation and ensures milestones are met throughout study lifecycle.* Manages recruitment and enrollments efforts for multiple clinical studies and trials.* Conducts and documents informed consent procedures for clinical studies, ensuring participant understanding and regulatory compliance.* Tracks and reports key metrics, including adverse events and protocol deviations, to compliance committees.* Designs and maintains infrastructure for scientific review, feasibility assessments, and projected effort analysis for clinical research protocols.* Process Improvement & Collaboration.* Establishes departmental goals and executes work procedures, practices, and clinical study guidelines.* Collaborates with principal investigators, physicians, research core laboratories, informatics team members, and vendors to facilitate study operations and cross-functional initiatives.* Partners with faculty to establish and monitor site performance metrics such as enrollment, retention, data quality, study start-up timelines, and incident rates. Leads root cause analyses and measures the impact of corrective or preventive actions.* Coordinates onboarding and activities with external contractors on specimen collection and documentation for study participants’ home visits.* Foster communication between research centers, sections, vendors, and regulatory agencies (e.g. FDA) for IND submissions and cross-references.* Conducts weekly/biweekly meetings with principal investigators to review study status, monitor study progress, and address any operational challenges.* Coordinate and tracks all Data and Safety Monitoring Board (DSMB) meetings, facilitating communication and documentation between internal and external collaborators.* Data Management & Monitoring.* Develops and maintains complex research study databases, collaborating closely with institutional data teams to ensure data integrity and security.* Demonstrates advanced proficiency in clinical study monitoring and auditing; leads and trains others in all aspects of quality assurance activities.* Manages database systems (e.g. REDCap) to ensure accurate data collection across multiple clinical research studies.* Proactively monitors patient safety and drug tolerability, assisting PI with real-time review.* Manages and directs the protocol review process for all clinical trials which includes the receipt and coordination of protocols for review, committee meetings, and clinical research conferences.* Advises the development of a formalized training program for both new and existing staff within the unit and any affiliates and/or partners. Monitors federal regulatory agency requirements related to clinical research training requirements and ensures training activities comply with requirements.* Manages PI and other senior research faculty and personnel, participates as a skilled individual contributor and/or lead researcher as expert in specialized area. Ensures research projects progress according to plan by overseeing the coordination of the daily clinical trial activities.* Performs other related work as needed.* Strong leadership, staff development, team management and mentoring skills.* Effective communication, stakeholder engagement and collaboration skills.* Excellent organizational and detailed documentation practices.* Expertise in regulatory affairs, regulatory compliance, quality assurance, ethical conduct, and policy adherence.* Advanced knowledge in regulatory affairs and reporting requirements.* Demonstrated experience managing complex protocols and multidisciplinary teams.* Direct experience preparing and submitting FDA regulatory documents and responding to agency queries.* Advanced proficiency in regulatory reporting, audits, monitoring, and compliance.* Proficient in clinical data management systems (EPIC, REDCap, or equivalent); experience developing and implementing data collection tools and quality assurance measures.* Proficient in mentoring, training and managing staff, projects and clinical trials.When applying, the document(s) **MUST** be uploaded via the **My Experience** page, in the section titled **Application Documents** of the application.The University of Chicago is an urban research university that has driven new ways of thinking since 1890. Our commitment to free and open inquiry draws inspired scholars to our global campuses, where ideas are born that challenge and change the world.We empower individuals to challenge conventional thinking in pursuit of original ideas. Students in the College develop critical, analytic, and writing skills in our rigorous, interdisciplinary core curriculum. Through graduate programs, students test their ideas with UChicago scholars, and become the next generation of leaders in academia, industry, nonprofits, and government.To learn more about the university click here #J-18808-Ljbffr