Job Description:

Job Requirements This position provides operational leadership, oversight, and coordination for research activities across the University of Maryland Medical System (UMMS). This role supports the development, implementation, and continuous improvement of standardized research processes to ensure safe, efficient, compliant, and high-quality research operations across all member organizations. Working closely with investigators, clinical service lines, research leadership, and system partners, the Manager streamlines workflows, strengthens regulatory compliance, improves performance metrics, and enhances research capacity. This position plays a key role in advancing systemwide research infrastructure and accelerating UMMS's ability to conduct high-quality research. Direct report to Senior Director, Research and Sponsored Programs Services and Operations. Primary Responsibilities 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 Education & Experience - Required
Bachelor's degree in health sciences, clinical research, healthcare administration, public health, or related field.
Minimum 5-7 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. Education & Experience - Preferred
Master's degree.
Experience in an academic medical center, hospital system, or large research organization.
Experience leading or supporting process improvement and systemwide standardization initiatives strongly preferred. Knowledge, Skills, & Abilities
Strong understanding of clinical research operations, study startup, regulatory requirements, budgeting, and protocol execution.
Excellent organizational, analytical, and problem-solving skills.
Strong interpersonal and communication skills with the ability to engage diverse stakeholders.
Ability to manage multiple projects and competing priorities simultaneously.
Proficiency in research systems such as CTMS, eRegulatory platforms, REDCap, and EHR-integrated research tools.
Demonstrated ability to lead change, build consensus, and promote operational best practices.
Strong sense of personal responsibility and accountability for delivering high quality work
Expert skill in the use of Microsoft Office Suite
Expert verbal, written and interpersonal communication skills Benefits All your information will be kept confidential according to EEO guidelines.

Compensation:

Pay Range:

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