Clinical Research Regulatory Coordinator, School of Medicine/Internal Medicine/Cardiology

 Pauley Heart Center

Department Summary:

Founded more than 20 years ago, the Pauley Heart Center is today the top-ranked heart center in Virginia, and one of only a handful of named heart centers in the nation. Headquartered at VCU Health in Richmond with outpatient centers throughout central and southeast Virginia, Pauley provides clinical services and community education and outreach programs throughout the region.

Cardiovascular disease (CVD) is the leading cause of death nationwide and in Virginia, and despite advances in prevention and treatment in recent decades, CVD disproportionately affects individuals with poor social determinants of health. Pauley's mission is to improve cardiovascular care and reduce health disparities for all through interdisciplinary, cutting-edge, clinical, translational and community-based research; training and developing the next generation of cardiovascular clinicians and researchers across all levels of education; and providing innovative and accessible cardiovascular procedural care (both surgical and catheter-based) that is the best in the Commonwealth. Pauley is a regional and national leader in research, education, and clinical programs involving electrophysiology; advanced cardiac imaging (MRI, CT, echo); advanced heart failure, including device-based treatments, total artificial heart, and heart transplant programs; cardio-oncology; high-risk percutaneous coronary interventions; adult congenital heart disease; and exercise-based cardiovascular disease prevention. Pauley also operates top-flight sub-specialty clinics and research programs investigating cardiac amyloidosis; cardiac sarcoidosis; and hypertrophic cardiomyopathy.

Position Summary: To serve in the key role of Regulatory Affairs Coordinator which will facilitate the successful launch and oversight of clinical research studies at Pauley Heart Center/Division of Cardiology Virginia Commonwealth University. This position supports pre-award, regulatory, and start-up activities to ensure that all institutional, sponsor, and federal requirements are met efficiently and accurately. Working in close collaboration with investigators, research teams, and administrative offices, the coordinator facilitates study activation from proposal development through study initiation, helping to reduce start-up timelines and maintain regulatory compliance. This role is ideal for a detail-oriented professional who thrives in a collaborative environment and is motivated to streamline research processes that advance the Pauley Heart Center mission.

This is a restricted position with no set end date continued employment is dependent upon project need, availability of funding, and performance.

Core Responsibilities:

Research Regulatory and Compliance Coordination (60%)
• Complete and/or support Pauley Heart Center and Cardiology Divisional research staff with the development and submission of documents to applicable regulatory agencies from study start up through completion (local and central IRBs, varying local committees, FDA, etc.)
• Research and provide best applicable regulatory pathways for investigator initiated trials, including drug and device studies
• Ensure compliance with FDA, NIH, and institutional regulations related to human subjects protection, Good Clinical Practice (GCP), and data security
• Provide support for and/or develop essential trial documents as needed for research projects and trials (protocols, ICFs, scripts, DCFs, data management plans, etc.).
• Track renewals, amendments, and continuing reviews to ensure ongoing compliance and study continuity
• Assesses and reports problems with study protocol and/or consent form compliance and intervenes appropriately
• Other duties as assigned related to research regulatory and compliance

Pre-award Coordination (40%)
• Assist faculty and study teams with preparation, review, and submission of grant and contract proposals including review of funding announcements
• Ensure pre-award materials meet all VCU, sponsor, and federal guidelines
• Coordinate internal routing and approval processes (RAMS-SPOT, Proposal Central, etc.) and ensure timely submission of proposals
• Coordinate with research finance and contracting offices to ensure budgets and scopes of work reflect regulatory and compliance requirements
• Track pre-award timelines and communicate updates to principal investigators and departmental/center leadership
• Collaborate with Division of Sponsored Programs (DSP) and departmental research administrators on budget revisions, just-in-time submissions, and funding notifications
• Other duties as assigned related to pre-award support

Qualifications:

Minimum Hiring Standards:
• Demonstrated ability to work in and foster an environment of respect, professionalism and civility with a population of faculty, staff, and students from all backgrounds and experiences, or a commitment to do so as a staff member at VCU.
• Knowledge of research development, execution, and administration.
• Excellent written, oral and interpersonal communication skills. Meticulous attention to detail for comprehension of nuanced regulations.
• Ability to manage multiple projects, multi-task and prioritize autonomously. Able to work in a fast paced, demanding environment and adapt to changing client status, regulations and work environment.
• Demonstrated knowledge of medical terminology. Demonstrated proficiency with multiple computer applications, including but not limited to: MS Word, MS Excel, spreadsheet management, PDF file creation/use, online database use.
• Requires analytical skills to resolve problems that require the use of basic scientific, mathematical or technical principles.

Required Education and Experience:
• Bachelor’s degree or relevant experience in a healthcare or academic research setting
• Must maintain appropriate certifications and trainings (e.g., CITI Human Subjects, GCP)
• Ability to work in a fast-paced, demanding, and diverse environment and adapt to changing client status, regulations, and work environment
• Demonstrated knowledge of medical terminology
• Excellent discretionary decision-making and problem-solving skills
• Independent, self-motivated, and organized
• Excellent written, verbal, and interpersonal skills

Preferred Qualifications
• 2+ years of experience in regulatory affairs for clinical research (especially in cardiovascular, translational, or academic medical center context)
• Experience with human subject research participants
• Experience with regulatory submissions/compliance to both local and central IRB’s

Salary Range: $55,000 - $70,000

Benefits: All full-time university staff are eligible for VCU’s robust benefits package that includes comprehensive health benefits, paid annual and holiday leave, generous tuition benefits, retirement planning and savings options, tax-deferred annuity and cash match programs, employee discounts, well-being resources, abundant opportunities for career development and advancement, and more.

FLSA Exemption Status: Exempt

Hours per Week: 40

Restricted Position: Yes

ORP Eligible: No

Flexible Work Arrangement: Hybrid

University Job Title: 3411B - Clinical Research Coordinator Base

Contact Information:
Contact Name: Cheyenne Taylor
Contact Email: [email protected]