Regulatory Affairs Coordinator, Remote

Regulatory Affairs Coordinator, Remote

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
34066N 34065N 34064N 34063N 34062N 34061N

Recruitment Pool
All Applicants

Posting Number
req6486

Unit
Massey Cancer Center MBU

Department

Department Website Link
https://www.masseycancercenter.org

Location
VCU

Address
VA USA

Duties & Responsibilities

Massey Comprehensive Cancer Center

The Massey Comprehensive Cancer Center has an exciting opportunity for a Regulatory Affairs Coordinator to join our team! Our employees and applicants come from diverse backgrounds. We hire great people from a wide variety of backgrounds, not just because it's the right thing to do, but because it makes VCU stronger. Please note flexible work arrangements are available for this position within 70 miles of Richmond, Virginia with regular visits to our Downtown Richmond location.

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

Please note that if you are employed as a university employee working in any of the health system's facilities, you will need to follow VCU Health System policies, which will include but will not be limited to, vaccination requirements.

VCU is committed to hiring veterans! VCU will include a veteran's period(s) of military service in the calculation of their annual leave accrual rate. This may provide veterans with an increased leave accrual!

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.

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).

Benefits of Working at VCU

At Virginia Commonwealth University (VCU), we believe that our strength lies in our diversity. As a premier institution in Richmond, VA, we are committed to fostering an inclusive environment that values and respects individuals from all walks of life. We don't just accept differences - we celebrate them, we support them, and we thrive on them for the benefit of our employees, our students, and our community. We are all different, and we believe it's these differences that make us stronger together.

Benefits of working at VCU include:

• New Employees (0-3 Years of Service) start with 28 days of paid leave per calendar year** plus federal and state holidays
• Leave plans built to promote a healthy work/life balance with the ability to carry leave forward to a following calendar year; parental leave for childbearing, caregiving, adoption, surrogacy, or foster care; caregiver leave for dependent immediate family members, community service leave for volunteer work, community participation, etc.
• Tuition Benefit for continuing education and professional development, up to six credit hours per academic semester
• Competitive Health Care Plan & FSA option through PayFlex
• Tax-deferred annuity retirement savings program with Cash Match Plan
• Professional development opportunities encouraged and offered for employees as part of annual career development, e.g. certifications, seminars, courses, annual conferences, mentorship, etc.

VCU's contributions in talent, innovation and entrepreneurialism, regional stewardship and local culture shape the economic impact and overall quality of life in the region. VCU as a whole generates more than $9 billion in economic activity. It is the largest employer in Richmond with more than 25,000 employees at VCU and VCU Health, and it supports approximately 58,000 jobs in Virginia. In addition, Virginia classifies VCU with a Tier III status - the highest possible status for universities and colleges - allowing VCU more flexibility in managing its operations to implement best practices and streamline processes. To learn about VCU's finances, visit about.finance.vcu.edu.

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
1/27/2025

Contact Information for Candidates

masseyhr@vcu.edu

Documents Needed to Apply