Manager Research Operations
Job Requirements
The following statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all job responsibilities performed. Manage daily operational activities supporting research across UMMS. Oversee study activation workflows, including feasibility, resource assessment, and regulatory readiness. Monitor operational performance metrics, dashboards, and KPIs to drive accountability and improvement. Provide operational guidance to investigators and clinical teams on research workflows and best practices. Support development and implementation of standardized policies, SOPs, and templates across UMMS. Participate in systemwide workgroups involving study startup, contracting, budgeting, coverage analysis, and regulatory coordination. Identify inefficiencies and implement solutions that improve study timelines, quality, and compliance. Partner with IT and system offices to optimize research systems such as CTMS, eRegulatory platforms, REDCap, and EHR research modules. Ensure operational compliance with federal regulations (FDA, DHHS, OHRP), ICH-GCP, sponsor requirements, and UMMS policies. Support IRB submissions, continuing reviews, amendments, reporting, and regulatory documentation. Coordinate with Research Review Committees (RRCs) to ensure consistent compliance expectations. Assist with audits, quality assurance activities, corrective action plans, and monitoring visits. Provide leadership and guidance for coordinators, research nurses, and other research staff. Support resource planning, staffing, and workload management across studies. Assist with recruitment and retention strategies, feasibility reviews, and enrollment monitoring. Promote subject safety practices, data integrity, and adherence to study protocols. Serve as a liaison between system research administration, site research offices, clinical teams, and external partners. Build strong working relationships with investigators, faculty, clinical leadership, and sponsors. Provide consultative support on operational requirements and policy interpretation. Develop and deliver training for investigators, coordinators, and research staff on research operations, GCP, compliance, and study conduct. Support workforce development initiatives to strengthen research competencies. Mentor junior research staff and foster a collaborative, high-performing culture. Perform all other duties as assigned.
Work Experience
Bachelors degree in health sciences, clinical research, healthcare administration, public health, or related field. Minimum 57 years of experience in clinical research operations, research administration, or related healthcare research functions. Demonstrated knowledge of human subjects research regulations, ICH-GCP, FDA requirements, and clinical trial operations. Prior supervisory or team leadership experience. Experience with Clinical Trials Management Systems Experience with EPIC or similar EMR as it relates to research. Clinical Research Professional certification (e.g., CCRC, CCRP, ACRP-CP, SOCRA) preferred or required within one year of hire.
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