Senior Clinical Research Coordinator, School of Medicine, Office of Research Administration

Virginia Commonwealth University (VCU) School of Medicine is a premier academic medical center located in the heart of Richmond. Accounting for almost half of VCU’s sponsored research, the School of Medicine is internationally recognized for patient care and education. All full-time university staff are eligible for VCU’s generous benefits package that includes: 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: https://hr.vcu.edu/careers-at-vcu/why-work-at-vcu/

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.

Position Summary:

The School of Medicine (SOM) Office of Research Administration is seeking a candidate with strong skills in clinical research coordination and management to join our clinical trials group (SOMCT). SOM is committed to supporting VCU clinical researchers in advancing medical science in our region. Clinical research is a continually expanding area in healthcare. This is a team lead position, with an opportunity to help build a team of clinical research professionals with advanced job responsibilities across a variety of clinical areas. This position provides an opportunity to work in a fast-paced environment with potential for career growth in the field of clinical research management for those presenting a willingness to learn and ability to work collaboratively with a diverse group of faculty and staff.

This position is a key part of the team focused on supporting SOM clinical investigators with activation and management of clinical trials in a positive and dynamic environment. This position reports to the Associate Director for Clinical Research Administration and Operations, where key responsibilities include:

• Maintain advanced understanding of clinical research management duties from study initiation to close-out.
• Maintain current CITI credentials for Human Subjects Protections, Good Clinical Practice (GCP), Clinical Research Coordinator, plus additional sponsor GCP certifications as required.
• Understand and adhere to all IRB requirements, Human Subjects protection regulations, and all aspects of IRB approved protocols.
• Be directly responsible for study coordination and regulatory management of an assigned portfolio of clinical research studies covering a variety of diseases and conditions.
• Serve as a senior research coordinator for an emerging central coordinator pool; work with leadership to lay the groundwork for expanding a coordinator pool, overall portfolio staffing and management.Assume responsibility for oversight of additional CRC staff as support needs grow.
• Train clinical research staff in the growing SOM Research Coordinator pool; participate in development and delivery of standard orientation and onboarding programs for CRCs school-wide.
• Serve as an ongoing resource for providing information and expert advice on clinical research issues.
• Lead the development of best practice guidance and work aids for CRCs in areas such as: study activation, study coordination, data management, and records management.
• Follow VCU and SOM internal processes to ensure compliance with VCU policies related to research activities and ensure compliance with federal and state regulatory standards.

Potential for limited telework on days when on-site/in clinic time is not required.

Primarily job hours: M-F, 8-5; however, an occasional need to shift schedule out of that time range may arise depending on study needs.

Minimum Qualifications:

• 3 years minimum direct experience managing study coordination and regulatory affairs for industry-sponsored clinical trials.
• Bachelor’s degree or equivalent applicable combination of training, education and experience.
• Strong communications skills, attention to detail and time management skills are key.
• Must possess the ability to set priorities, make timely decisions and meet deadlines while working on multiple projects.
• Ability to work collaboratively and cooperatively in a large and complex organization and in a diverse and fast-paced work environment.
• Must be able to complete mandatory competencies and certifications required by VCU and VCUHS, individual clinical trials and the NIH Human Subjects Protection training.
• Demonstrated experience working in and fostering a diverse faculty, staff, and student environment or commitment to do so as a staff member at VCU.

Preferred Qualifications:

• 5 or more years direct experience in clinical research management; prior experience at an academic medical center strongly preferred.
• Experience managing multi-site trials, consortium studies, and/or large complex clinical research programs
• Active clinical research certification, e.g., SOCRA, ACRP, or ability to obtain certification
• Active clinical licensure such as CMA, CAN, EMT, RN, LPN.

Position will remain open until filled.

This is a restricted position and continued employment is dependent upon project need, availability of funding, and performance.

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.