Clinical Research Regulatory Coordinator Role with Competitive Salary in Richmond

16 hours ago

Richmond, California, United States Commonwealth of Virginia Full time

About Us

Virginia Commonwealth University (VCU) School of Medicine is a leading academic medical center situated in the heart of Richmond, Virginia.

We are committed to delivering exceptional patient care and education, while accounting for nearly half of VCU's sponsored research.

The university offers a generous benefits package, including competitive health benefits, paid annual and holiday leave, retirement planning and savings options, tax-deferred annuity and cash match programs, Virginia Retirement System (VRS), professional development & certifications, tuition waiver, parental leave, caregiving leave and community service leave. Learn more about VCU's benefits here: vcu.edu/hr/benefits.

Virginia Commonwealth University is an equal opportunity, affirmative action university providing access to education and employment without regard to race, color, religion, national origin, age, sex, political affiliation, veteran status, genetic information, sexual orientation, gender identity, gender expression, or disability.

Job Overview and Primary Responsibilities

The Clinical Research Office (CRO) within the School of Medicine (SOM) at Virginia Commonwealth University seeks a dedicated Clinical Research Regulatory Coordinator to join our team.

This role plays a vital part in supporting SOM clinical research study teams with the management of clinical trials in a dynamic environment. The successful candidate will work under the direction of the Associate Director for Clinical Research Operations to ensure regulatory compliance and manage clinical trials efficiently.

Key Responsibilities:

  • Regulatory Management and Study Activation (60%): Provide direct regulatory management for assigned SOM Clinical Trials, maintain and organize regulatory documents, prepare and manage IRB documents and protocols, ensure regulatory compliance, and possess knowledge of FDA guidelines and GCP/ICH regulations.
  • Support and Assist SOM Study Teams (20%): Offer education and guidance to investigators on regulatory compliance, work with the CRO Training Coordinator to develop tools aligning with regulatory requirements, coordinate site selection visits, ensure OnCore study team task lists are up-to-date, participate in pre-study planning meetings, complete PROC and intake forms, and assist with training CRCs on required regulatory documentation.
  • Establish Standard Operating Procedures to Support Regulatory Compliance (10%): Create Standard Operating Procedures that align with VCU Clinical Research Regulatory best practices, ensure compliance with School of Medicine policies and procedures, follow internal processes to ensure federal and state regulatory standards, and lead the development of best practice guidance and work aids for CRCs.
  • Excellence in Customer Service and Collaboration (10%): Provide ongoing support for clinical research operations and administration, offer expert advice on regulatory compliance, regularly assess VCU SOM CRC performance by performing quality control checks, and serve as an ongoing resource for providing information and expert advice on regulatory compliance.

Minimum Hiring Standards:

  • Demonstrated knowledge of federal regulations, protection of human subjects, and HIPAA.
  • Ability to analyze, interpret, and implement complex Federal, State, and sponsor regulations.
  • Mastery of GCP/ICH guidelines for clinical studies.
  • Bachelor's degree or equivalent experience.
  • At least 2 years of direct Clinical Research Coordinator experience.
  • 1 or more years' experience in Clinical Research Regulatory affairs.
  • Demonstrated understanding of clinical research, including all types and funding sources.
  • Maintain CITI credentials for Human Subjects Protection and Good Clinical Practice (GCP).
  • Excellent oral and written communication skills.
  • Ability to set priorities, make timely decisions, and meet deadlines.
  • Comfortability working in and fostering a diverse faculty, staff, and student environment.
  • Extremely organized and detail-oriented.
  • Strong communications skills, attention to detail, and time management skills.
  • Demonstrated commitment to fostering diversity and inclusion in past experiences or as a staff member at VCU.

Preferred Hiring Standards:

  • Regulatory management of multi-site studies.
  • Clinical research certification or ability to obtain.
  • Experience in an academic medical center environment.
  • Prior experience using OnCore or other clinical trial management systems.
  • Advanced degree in healthcare, research, or education.
  • Knowledge of VCU and/or VCU Health.
  • Experience utilizing EPIC (Electronic Medical Record).
  • Proficient with Microsoft Office Suite.
  • Active clinical research certification, e.g., SOCRA, ACRP, or ability to obtain certification.

This position is remote-hybrid eligible (40%-60% remote work). The selected candidate must be able to come into the office on VCU's MCV-Health Campus when needed as office days may vary weekly.

Position will remain open until filled. The School of Medicine continuously strives for our workplace and learning environment to reflect the demographic and social milieu of the communities we serve. All qualified applicants are encouraged to apply. 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.

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