Regulatory Affairs Coordinator Benefits of working at VCU All full-time university staff are eligible for VCU's robust benefits package that includes: comprehensive health benefits, paid annual and holiday leave granted up front, generous tuition benefit, 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. Learn more about VCU's benefits here. Job Code 34111N Recruitment Pool All Applicants Posting Number req6486 Unit Massey Comprehensive Cancer Ctr MBU Department Department Website Link https://www.masseycancercenter.org Location VCU Address VA USA Duties & Responsibilities Please note VCU is not able to provide current or ongoing visa sponsorship for this position. Benefits At a Glance * 28 Vacation Days, 12+ State Holidays, and 4 Days to volunteer; * Continuing education for undergraduate and graduate tuition for a maximum of 6 credits per semester; * Professional development opportunities encouraged and offered for employees as part of annual career development, e.g. certifications, seminars, courses, annual conferences, mentorship; * Medical, Dental and Vision Health Benefits to meet the needs of employees and their eligible family members from the Commonwealth of Virginia as well as optional FSA; * Participation in the Virginia Retirement System (VRS) and other retirement saving options; * Parental and Caregiver Leave, Short Term Disability (STD), Disability Insurance, Voluntary Long Term Care Insurance, and Employee Assistance Program. Massey Comprehensive Cancer Center Mission: To reduce the state cancer burden for all Virginians by addressing the confluence between biological, social, and policy drivers through high-impact, cutting-edge research; person-centered care across the continuum, from prevention through survivorship; community integration; and training the next generation of community-centric researchers and healthcare professionals Vision: To be a premier community-focused cancer center leading the nation in cancer health equity research and ensuring optimal health outcomes for all Position Primary Purpose and General Responsibilities * Deliver exceptional Institutional Review Board (IRB) and related regulatory support to the Principal Investigator (PI) and research team ensuring: 1) adherence to the protocol; 2) regulatory compliance; 3) protection of participant safety and welfare. * Provide IRB and related regulatory support to the PI and members of the research study team throughout the life of the study (activation to closeout). * Ensure safety of research participants and endeavor to minimize risk to the institution, center and PI by maintaining audit-ready regulatory files at all times and uploading currently approved protocols, informed consents and PRMC approvals in OnCore upon receipt. * Monitor study activities to ensure all requisite regulatory approvals are on file prior to the research team consenting / enrolling research participants at Massey or an affiliate site. * Proficient utilization of electronic research systems/databases to ensure timely submissions and compliance with multiple IRBs and related regulatory entities. Qualifications Minimum Qualifications * Massey Comprehensive Cancer Center supports a diverse faculty, staff, and student environment. The candidate will demonstrate experience that shows their commitment to fostering such an environment. * Bachelor's degree or equivalent experience, education and training in an academic medical center Independent judgment and critical-thinking skills required. * Ability to demonstrate successful implementation of time management skills. * Ability to multi-task and prioritize autonomously. * Demonstrated leadership experience. * Exceptional attention to detail and data accuracy. * Ability to work in a fast paced, demanding environment and adapt to changing client status, regulations and work environment. * Detail-oriented, exceptional organizational skills. * Proficient with multiple computer applications, including but not limited to: Microsoft Word, Microsoft Excel, spreadsheet management, PDF file creation/use, online database use/maintenance, internet-based research, network & online file maintenance & management, and custom report generation. * Demonstrated knowledge of medical terminology. * Ability to provide own transportation to attend meetings within the service area or at training locations. Candidates whose resumes highlight the following previous experience will be prioritized: * Demonstrated experience working in and fostering an environment of respect, professionalism and civility with a population of faculty, staff, and students from various backgrounds and experiences, or a commitment to do so as a staff member at VCU; * Intermediate proficiency with data entry and word processing skills, with the ability to analyze and interpret information effectively; * Intermediate organizational abilities and a keen eye for detail to ensure accuracy and efficiency in all tasks; Clear and professional written and verbal communication skills, with the ability to interact effectively with colleagues and stakeholders; * Interpersonal skills, capable of building relationships and collaborating with team members at all levels to gather information and support compliance efforts; * Problem-solving and organizational aptitude, with the ability to manage multiple tasks and meet deadlines in a dynamic environment. Please note VCU is not able to provide current or ongoing visa sponsorship for this position. Preferred Qualifications * Experience with oncology standard care practice and/or research protocols. * Experience in clinical research or regulatory management * Experience with NCI-sponsored cooperative group, private industry and investigator-initiated trials. * Experience with Oncore or other clinical trial management systems (CTMS). FLSA University Employee Job FTE 1 Exemption Status Exempt Restricted Position E-Class UF - University Employee FT Job Category University Employee ORP Eligible No Salary Range Starting at $51,000 commensurate with experience Compensation Type Salaried Target Hire Date 6/16/2025 Contact Information for Candidates [email protected] Documents Needed to Apply