Summary

This position serves as the regulatory coordinator for the Parkinson's & Movement Disorder Center. In this role, the individual is required to provide regulatory expertise across a broad portfolio of projects, including federally-funded investigator-initiated studies, industry-sponsored clinical trials, and a variety of foundation-sponsored projects. This individual is responsible for clinical regulatory document submission and maintenance across the program. In this role, the individual works closely with the regulatory team and network coordinator to facilitate regulatory document submissions. Under the direction of the Principal Investigator (PI), collaborates with all members of the clinical research team to ensure all federal, state, university, and protocol requirements are followed, institutional research objectives are met, and that ethical obligations are kept.

Typical Duties

Regulatory Management
- Maintain clinical research regulatory documents for studies including informed consent forms, protocols, manuals and training logs etc. in compliance with federal regulations, ICH and GCP guidelines
- Prepare and manage IRB documents and protocols for submission
- Work with network coordinators and investigators on ensuring regulatory compliance on all active and future studies

Regulatory Oversight
- Coordinate program staff and study staff training as it relates to regulatory compliance
- Stay up to date on internal trial development and submission policies
- Contribute to policy and procedure development, review, training and evaluation

Regulatory Activation
- Create and maintain study binders for all industry and investigator initiated clinical trials including trial master file, investigator site files and program training files.
- Coordinate with investigators, pharmacy, clinics to ensure smooth patient progression through study
- Will complete all required training sessions, internally and externally

Minimum Qualifications

- Experience conducting clinical research while working within IRB, Federal and state regulatory guidelines
- Highly competent with computer software, including database, spreadsheet and word processing applications
- Bachelor's degree or equivalent training/experience
- Demonstrated experience working in and fostering a diverse faculty, staff, and student environment or commitment to do so as a staff member at VCU.
- 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:

- Experience in human subjects research in participants with movement disorders
- Familiarity with eTMF software, RedCap and/or RedCap Cloud
- Experience working on federally funded, investigator-initiated and investigator-held studies
- Experience working on industry-sponsored clinical trials

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 our generous benefits package that includes choices for health, vision, and dental coverage, life-insurance, short and long-term disability coverage, retirement planning, tax-deferred annuity and cash match programs, flexible spending accounts, tuition benefits, significant paid-time off, 12 paid holidays, and more. Explore our benefits further here: https://hr.vcu.edu/current-employees/benefits/university-and-academic-professional-benefits/

This position is open until filled.

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

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.

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.

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.

ORP ELIGIBLE: NO

UNIVERSITY JOB CODE: Clinical Research Coordinator 1-3