Clinical Research Coordinator, Department of Surgery

Position Summary and Primary Responsibilities: The Department of Surgery is recruiting for a Clinical Research Coordinator. This position will provide exceptional support to all ORBIT activities. This includes coordinating, creating, and monitoring all IRB and related regulatory compliance systems with the PIs and members of the research study teams throughout the life of the studies. This position will ensure audit-ready regulatory files are maintained at all times and will require proficient utilization of VCU’s many electronic research systems/databases to ensure timely submissions and compliance with multiple IRB and related regulatory entities. This position will also provide significant clerical assistance to ORBIT associate chairs, supervisor, principal investigators, and research teams.

General Duties

Research Compliance (30%): Coordination of IRB/IACUC or other regulatory approvals for initial protocols and all amendments; Preparation and submission of new protocols to the IRB/IACUS and other regulatory agencies. Accurate interpretation of institutional and federal policy guidelines as they relate to research and funded projects; Attend meetings with Principal Investigator, research team, affiliate staff and sponsors as necessary at team / sponsor / affiliate site locations; Maintain audit ready regulatory “binder ” to include all generally recognized regulatory essential documents; Attend and provide support for sponsor audits, providing support and document as requested; Attend and participate in study initiation, start-up, monitoring and close-out visits as required per sponsor, Principal Investigator and/or study team.

Research Systems & Database Support (30%): Ensure consistent, high quality and timely data entry and routine updates to multiple research related databases; Update and maintenance of IRB “review”, “status”, “checklist” and approval” sections in OnCore; Assist Principal Investigator and protocol research staff with questions about how to use specific electronic IRB systems for effective submission, review and response to IRB panels. Develop proficiency with all research systems and databases and query functions to access data for report generation; Collects necessary regulatory data in timely manner; promptly enters into research system / database; Generate research related reports in a timely manner.

Conduct of Research (30%): Reviews and develops a familiarity with the study protocol, e.g, proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections. Works with the PI to develop and implement recruitment strategies. Conducts or participates in the informed consent process. Screens subjects for eligibility. Coordinates participant tests and procedures. Maintains adequate inventory of study supplies. Collects and enter data as required by the protocol.

Administrative Work (10%): Provide clerical assistance to Principal Investigators and members of the research team; Provide back-up assistance to clinical research coordinators as needed; Respond to directives, participate in grant application process and site visits, and provide information in written and oral form as requested; Provide support for special projects as identified / assigned; Actively supports team and other business units in completion of critical tasks; Perform other duties as assigned

Required Education & Experience:

• Ability to prioritize, focus, work independently and be flexible when the unexpected occur
• Excellent, demonstrated oral and written communication skills
• Excellent customer service skills
• Ability to work well in a team environment and to work with individuals from diverse backgrounds
• Ability to set priorities and to work comfortably in a fast-paced, deadline driven environment
• Exceptional interpersonal and communication skills and demonstrated ease problem solving in group settings
• Ability to readily accept routine interruptions in order to meet “real time” / “just in time” learning needs and support of co-workers
• Ability to demonstrate successful implementation of time management skills
• Ability to multi-task and prioritize autonomously
• Exceptional attention to detail and data accuracy
• Proficient with multiple computer applications, including but not limited to: Microsoft Word, Microsoft Excel, spreadsheet management, PDF file creation/use, online EDC database/maintenance, web-based research, network & online file maintenance & management, and custom report generation.
• Demonstrated experience fostering a diverse faculty, staff, and student environment or a commitment to do so at VCU

Preferred Education & Experience:

• Bachelor’s degree or equivalent combination of education and experience
• Research experience in an academic medical center strongly desired

Additional Information

University Title : Clinical Research Coordinator (Open), Research & Innovation

ORP Eligibility : No

Vaccination Requirements : 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.

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

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. VCU School of Medicine comprises 18 clinical departments, eight basic health science departments, and 11 affiliated institutes and centers, and provides preeminent education to physicians and scientists in order to improve the quality of healthcare for humanity. 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/

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.