Clinical Research Manager, Research Incubation Unit

University of Chicago•Chicago, IL

1d•Onsite

About The Position

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. Its mission 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. The Clinical Research Manager 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. This role involves managing strategic, administrative, operational, and financial decisions impacting clinical research across the University. The manager is part of the Research Incubation Unit, established to grow clinical research portfolios and provide short-term clinical research management services. Key responsibilities include recruiting, onboarding, and training new clinical research staff; day-to-day management and supervision; supporting study initiation and completion of milestones; tracking and reporting metrics; communicating with investigators, department leaders, industry sponsors, and internal stakeholders; and fulfilling service level agreement performance standards. This position reports to the Director of Clinical Research Operations within the Office of Clinical Research.

Requirements

A college or university degree in a related field.
7+ years of work experience in a related job discipline.

Nice To Haves

Master's Degree.
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.
ACRP / SOCRA research certification.
Mentors or trains others to communicate effectively with CRO and/or sponsor, and in managing and conducting site visits.
Understands the relationship between sites, sponsors and CROs in order to solve problems.
Creates and maintains departmental infrastructure for scientific review, feasibility assessment and projected effort/protocol.
Determines and manages complex study and equipment resources for more than one study, and processes related to their management.
Forecasts study needs, including staffing.
Effectively solves complex problems related to managing resources.
Ensure that multiple studies are conducted in compliance with institutional requirements and other policies.
Mentor others in this area.
Develops, follows, and implements detailed complex operational plans for research protocol(s) (those that require coordination of multiple units or services).
Partnering with faculty set site performance metrics and targets: enrollment, retention, data quality, start-up timeline, Unanticipated Problem rate etc. and works with team to understand root cause of metric in non-conformance and take appropriate actions.
Measures impact of preventive and corrective actions.
For complicated scenarios, recognizes when all types of agreements (MTAs, CTAs, CDAs, DUAs, DTAs, etc.) are necessary and which procedures to follow, including special terms that may need to be included.
Prepares and maintains FDA regulatory submissions on more than one PI-initiated study overseen by the FDA.
Handles complex situations and/or potential hold issues directly with the FDA, in collaboration with the PI.
Demonstrates advanced application and knowledge of monitoring and audits.
Trains or leads others in most tasks related to monitoring and audits.
Sets meeting objectives, goals and detailed agendas for multidisciplinary meetings.
Mentors or trains others in meeting preparation and follow up.
Facilitate healthy communication during meetings.
Conduct and document informed consent for multiple interventional and/or complex studies.
Exhibit additional knowledge or skills in consent procedures.
Advanced understanding of sponsor/regulatory reporting.
Independently develops, or guides the development, of multiple complex data entry or collection protocols and tools.
Systems are developed to ensure quality of data.
Trains others in collecting and entering data.

Responsibilities

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.