Clinical Research Coordinator- School of Medicine / Orthopaedic Surgery

Position Summary:

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.

This position is to assist principal investigators with new and ongoing clinical research studies: participating in all aspects of study formulation, study practice, and study patient admission. The position coordinates the enrollment and evaluation for patients on clinical research trials in the Department of Orthopaedics in collaboration with all members of the health care team. It serves as a case finder for potential clinical trails patients. Responsible for effective implementation of experimental treatments and use of research tools. It serves as the Primary contact resource for selected research protocols and is responsible for the coordination of patient care and data collection methods. Identify potential studies, study regulatory submission, assist in budget development, study setup, identify potential subject, consent subject with subject and hospital personnel to ensure adherence to study protocol and GCP, through to closeout and study record maintenance of those trials that the division has completed.

Core Responsibilities:

1. Performance Management

• Expectations are clear, well communicated and relate to the goals and objectives of the department or unit.

• Staff receive frequent, constructive feedback.

• Staff have the necessary knowledge, skills, and abilities to accomplish goals.

• The requirements of the performance management system are met, and evaluations are completed by established deadlines with proper documentation.

• Performance issues are addressed and documented as they occur.

• Safety issues are reviewed and communicated to ensure a safe and healthy workplace.

2. Regulatory Management Study/Coordination

• Responsible for the initial regulatory submission process and maintenance of regulatory approvals throughout the course of each study.

• Responsible for 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, ensure 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.

• Work closely with managers, administrators, and fiscal technician to ensure timely processing of participant payment of internal and external invoices and completion of labor distribution allocation.

• 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.

3. 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.

4. Reporting/Communication

• Maintain/update database for study participants.

• Accurately complete case reports and subsequent queries in a timely manner.

• 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.

• Leads monitoring audits and visits with study sponsors.

5. 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.

• Coordinate drug storage within the University’s approved drug storage facilities.

• Other activities as assigned.