Clinical Research Coordinator | Orthopedic Surgery |SOM | 611430

About the role

The Department of Orthopaedic Surgery at VCU School of Medicine provides care for a wide range of orthopedic conditions and diseases. Our vision is to be the premier orthopaedic provider in the central Virginia region. The Clinical Research Coordinator is responsible for conducting clinical trials using good clinical practice under the auspices of the Principal Investigator.

Responsibilities

The general purpose of the Clinical Research Coordinator is to perform all aspects of conducting assigned clinical research studies and trials including regulatory oversight, coordinating trial conduct, data management, communication with sponsors, and collaboration with organizational stakeholders.

• Regulatory Management: initial regulatory submission process, maintenance of regulatory approvals, and development of standard operating procedures manual for each assigned clinical trial
• Study/Coordination: working with Principal Investigator(s) to coordinate medical aspects of trials, evaluating patients for eligibility, gaining consent, and treating subjects
• Trial/Study Enrollment: creating and updating individual study screening plans, identifying enrollment goals, and scheduling enrollment visits
• Reporting/Communication: maintaining/updating database for study participants, completing case reports, and generating regular reporting
• Data Management/Other Duties: ensuring all study records are current, accurate, and complete, maintaining hard-copy and electronic documents, and ordering study supplies and medications

Qualifications

• Project management skills required
• Ability to work effectively and efficiently, must be self-directed and motivated
• Analytical skills to resolve problems requiring basic scientific, mathematical, or technical principles
• Effective communication skills with patients, family members, medical personnel, sponsors, and other university collaborations
• Ability to prioritize and meet deadlines
• Demonstrated ability to work in and foster an environment of respect, professionalism and civility

Preferred Qualifications: Bachelor’s degree in scientific or healthcare related field, prior experience with regulatory compliance, research coordination, knowledge of FDA regulations and guidelines, CITI training, and good clinical practice training.

Benefits

All full-time university staff are eligible for VCU’s robust benefits package that includes:

• Comprehensive health benefits
• Paid annual and holiday leave
• Generous tuition benefits
• Retirement planning and savings options
• Tax-deferred annuity and cash match programs
• Employee discounts
• Well-being resources
• Abundant opportunities for career development and advancement

Pay

Salary Range: $45,000-$55,000, Commensurate with experience

Schedule

FLSA Exemption Status: Exempt, Hours per Week: 40, Restricted Position: Yes, ORP Eligible: No, Flexible Work Arrangement: Fully Onsite