Clinical Research Coordinator | Orthopedic Surgery |SOM

Position Overview

The Clinical Research Coordinator is responsible for conducting clinical trials using good clinical practice under the auspices of the Principal Investigator. 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 trail conduct, data management, communication with sponsors, and collaboration with organizational stakeholders.

Duties & Responsibilities

• Regulatory Management
• Initial regulatory submission process and maintenance of regulatory approvals throughout the course of each study.
• Developing standard operating procedures manual for each assigned clinical trial.
• Working with Principal Investigator(s) to coordinate the medical aspects of trials.
• Evaluate patients for eligibility to participate in research trial, gain consent, and treat subject, ensuring that study treatments are carried out per protocol and that participants are provided all required documentation by the study team.
• Train clinical staff in recruitment practices including documenting basic data to facilitate studies.
• Collects data for all required regulatory agencies and studies accurately and on time, reports problems according to the designated process.
• Ensures proper collection, storage and shipping of specimens and handling of hazardous waste products in accordance with Federal regulation, University policy, and protocol requirement.
• Oversee reimbursement of subjects for study participation and maintain proper documentation in accordance with VCU Procurement Guidelines.
• Alert the PI of any serious adverse events that may occur throughout the course of the study.
• Abide by all University, Federal, State, Foundation, and industry guidelines regarding clinical research.
• Trial/Study Enrollment
• Work closely with PI at the onset of each trial to create, maintain, and update individual study screening plans and identify enrollment goals.
• Make decisions regarding potential participant’s eligibility for studies based on chart reviews, in person, and telephone screenings based on study protocol specifications.
• Schedule enrollment visits weekly using clinical scheduling system.
• Maintain/update database for study participants.
• Generate regular reporting regarding process of enrollment, status of subjects, events, and reimbursement reports.
• Coordinate regularly scheduled meetings with PIs and administration to communicate study progress/challenges and share regular reports.
• Prepare subject related correspondence and maintain related records.
• Lead monitoring audits and visits with study sponsors.
• Data Management/Other Duties
• Ensure all study records, documentation is kept current, accurate, and complete.
• Maintain all hard-copy and electronic documents and all relevant study communications for files.
• Maintain study records according to sponsor and university specifications.
• Order study supplies and medications.
• Collapse drug storage within the University’s approved drug storage facilities.
• Other duties as assigned.

Qualifications

• Minimum Qualifications: Project management skills required. Ability to work effectively and efficiently, must be self-directed and motivated. Requires the analytical skills to resolve problems requiring basic scientific, mathematical, or technical principles. Skills to effectively communicate 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 with a population of faculty, staff, and students from all backgrounds and experiences, or a commitment to do so as a staff member at VCU.
• Preferred Qualifications: Bachelor’s degree in scientific or healthcare related field preferred. Prior experience with regulatory compliance, research coordination, knowledge of FDA regulations and guidelines. CITI training, good clinical practice training strongly preferred.

Salary Range

$45,000-$55,000, Commensurate with experience

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, and more.

FLSA Exemption Status

Exempt

Hours per Week

40

Restricted Position

No

ORP Eligible

No

Flexible Work Arrangement

Fully Onsite