Clinical Research Coordinator, School of Medicine / Orthopaedic Surgery
- Employer
- Virginia Commonwealth University
- Location
- Richmond, Virginia, United States
- Salary
- Competitive Salary
- Date posted
- Jan 22, 2025
View more categoriesView less categories
- Position Type
- Faculty Positions, Medicine, Surgery, Administrative, Academic Affairs, Research Administration
- Employment Type
- Full Time
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Clinical Research Coordinator, School of Medicine / Orthopaedic Surgery
Benefits of working at VCU
All full-time university staff are eligible for VCU’s robust benefits package that includes: comprehensive health benefits, paid annual and holiday leave granted up front, generous tuition benefit, 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. Learn more about VCU’s benefits here .
Job Code Clinical Research Coordinator 1-3 (34111 - 34113)
Recruitment Pool All Applicants
Posting Number req6785
Unit School Of Medicine MBU
Department Orthopaedic Surgery / 1606
Department Website Link
Location MCV
Address MCVP Campus, Richmond, VA 23298 USA
Duties & Responsibilities
Summary:
The Clinical Research Coordinator assists principal investigators with new and ongoing clinical research studies; participating in all aspects of study formulation, study practice, and study patient admission. The incumbent coordinates the enrollment and evaluation for patients on clinical research trials in the Department of Orthopaedic Surgery in collaboration with all members of the health care team. Serves as a case finder for potential clinical trial patients. Responsible for effective implementation of experimental treatments and use of research tools. Serves as the primary contact resource for selected research protocols and is responsible for the coordination of patient care and data collection methods. The coordinator will identify potential studies, study regulatory submission, assist in budget development, study setup, identify potential subjects, consent subjects, work with subjects 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.
Typical Duties
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) coordinate the medical aspects of trials: Evaluate patients for eligibility to participate in research trial, gain consent, and treat subjects; 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 and 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 requirements.
• 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, processing and 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
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
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
Data Management / Other Duties
• Ensure all study records, documentation are 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
Qualifications
Essential Qualifications
• Bachelor’s degree or equivalent applicable combination of training, education, and experience.
• Minimum of 3 years’ direct experience managing study coordination and regulatory affairs for industry-sponsored clinical trials
• Strong communications skills
• Strong attention-to-detail and time management skills
• Ability to work collaboratively and cooperatively in a large, fast-paced, and complex organization
• Must be able to complete mandatory competencies and certifications required by VCU and VCUHS, individual clinical trials and the NIH Human Subjects Protection training
• Knowledge of FDA regulations and guidelines
• 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
• Bachelor’s degree in scientific or healthcare related field.
• Ability to work effectively and efficiently, self-directed, and motivated
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.
VCU is committed to hiring veterans! VCU will include a veteran's period(s) of military service in the calculation of their annual leave accrual rate. This may provide veterans with an increased leave accrual!
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.
FLSA University Employee
Job FTE 1
Exemption Status Exempt
Restricted Position Yes
E-Class UF - University Employee FT
Job Category University Employee
ORP Eligible No
Salary Range $45,000 - $55,000/annually
Compensation Type Salaried
Target Hire Date 1/22/2025
Contact Information for Candidates
Mario Lacic
mario.lacic@vcuhealth.org
Documents Needed to Apply
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