Oversee Departmental Clinical Research Portfolio across the lifecycle for each protocol from feasibility, startup, recruitment, day-to-day conduct, follow up through study close out.
Coordinate departmental clinical research staff and faculty meetings.
Oversee the conduct of clinical research, regulatory compliance, and IRB filings for all projects in the departmental portfolio.
Establish documentation standards for departmental scientific review and feasibility for all proposed clinical research projects.
Establish departmental standard work and standard operating procedures.
Monthly Reports of site performance and percent effort reports.
Training and onboarding of all research staff in GCP, 21 CFR 11, 21 CFR 312, 21 CF 812 and divisional policies for the conduct of clinical research.
Management and supervision for all Research Incubator clinical research staff.
Establish professional relationships with Contract Research Organizations, Pharmaceutical Sponsors, Funders and Grantors.
Collaboration with departmental, Research Incubator, and divisional stakeholders for clinical research.
Works with leadership, advisory compliance committee members and research unit leaders to establish a culture of research compliance.
Advises the development of a formalized training program for both new and existing staff within the unit and any affiliates and/or partners.
Plans and manages the protocol review process for all clinical trials which includes the receipt and coordination of protocols for review, committee meetings, and clinical research conferences.
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.
Requirements
Education:
Minimum requirements include a college or university degree in related field.
Work Experience:
Minimum requirements include knowledge and skills developed through 7+ years of work experience in a related job discipline.
Certifications:
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Master's Degree strongly preferred.
Experience with both industry sponsored FDA regulated clinical trial and investigator initiated clinical trial site management.
Regulatory support for FDA and IRB filings.
Protocol development support experience.
Licenses and Certifications:
ACRP / SOCRA research certification.
Preferred Competencies
Mentors or trains others to communic
Benefits
Health insuranceVision insurance
Additional Information
Department
BSD OCR - Clinical Research Operations
About the Department
The Office of Clinical Research (OCR) is the nucleus of the clinical research enterprise, providing services, training, tools and compliance oversight to support the conduct of clinical research across the entire Biological Sciences Division and University of Chicago Medicine human subject research portfolio.The mission of the Office of Clinical Research is to catalyze clinical research by providing expertise, resources, infrastructure, and systems that facilitate clinical research operations and enable collaboration across the enterprise while promoting compliance and human subject protection on behalf of our diverse community of patients and volunteers. Together, we elevate the human experience with knowledge and health care.
Job Summary
The job manages a team of professional staff responsible for performing clinical research including the collection, documentation, analysis of clinical trial data, and reporting of clinical research data. Manages the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University.
The Clinical Research Manager is part of the Research Incubation Unit of the Office of Clinical Research. The Clinical Research Incubation Unit was established to enable growth of clinical research portfolios across the Biological Sciences Division as well as provide timely research staffing services to departments or units in need of short-term clinical research management services. The Clinical Research Manager manages a team of professional staff responsible for clinical research conduct , research participant management, data management, and regulatory. Key responsibilities of the Manager include recruiting, onboarding, and training of new clinical research staff; day-to-day management and supervision of clinical research staff; supporting study initiation and completion of key milestones throughout the life cycle of the trials; tracking and reporting on key metrics; communicating with investigators and department leaders; communicating with industry sponsors and internal stakeholders; and fulfilling service level agreement performance standards. This position will have primary accountability to the Director of Clinical Research Operations within the Office of Clinical Research.
Uchicago · Chicago, IL