Clinical Research Coordinator IV - Oncology
About The Position
The Clinical Research Coordinator IV in Oncology manages administrative activities associated with industry-sponsored, grant-funded, and internally funded research studies while maintaining compliance with governing agency guidelines and institutional policies. The coordinator serves as a liaison among research sponsors, site management organizations, the local Institutional Review Board (IRB), physicians and staff, and Research and Development. The role involves recruiting, screening, and enrolling participants; obtaining informed consent; managing study documentation; coordinating communications and study implementation; monitoring enrollment goals; and organizing study visits and participant support. The coordinator collects data from medical records and other sources, processes and ships specimens as directed by study protocols, and ensures compliance with protocols and regulatory requirements. Responsibilities also include tracking adverse events and protocol deviations, coordinating monitoring and audit visits, and preparing and maintaining regulatory submissions and study records. The position requires managing multiple complex studies and significant workload, mentoring junior and intermediate clinical research coordinators, contributing to trial planning and implementation, and educating research teams and ancillary departments. The coordinator also supports protocol feasibility assessments, data collection systems, reporting, and the preparation of grant proposals, manuscripts, study materials, brochures, and correspondence, and acts as a champion for clinical research at Carilion Clinic.
Requirements
- Bachelor's degree in science or a related field.
- Either at least 10 years of clinical research or equivalent research experience and a master's degree in science, or at least 15 years of clinical research or equivalent research experience and a bachelor's degree in science.
- Nationally recognized clinical research certification from SoCRA or ACRP required upon hire.
- I.A.T.A. certification required for projects transporting specimens, before completion of the IRB application.
- Excellent computer skills, including knowledge of word processing, spreadsheets, databases, and internet environments.
- Strong organization and communication skills.
- Ability to work with multiple interruptions and perform multiple tasks at a time.
- Strong leadership, interpersonal, and teamwork skills.
Nice To Haves
- Master's degree in science or a related field.
- Knowledge of medical and/or pharmaceutical terminology.
Responsibilities
- Manage administrative activities for industry-sponsored, grant-funded, and internally funded research studies while maintaining compliance with governing agency guidelines and institutional policy.
- Serve as liaison among research sponsors, site management organizations, the local IRB, physicians and staff, and Research and Development.
- Recruit, screen, and enroll eligible study participants.
- Obtain informed consent from study participants.
- Manage completion and submission of study-related documentation.
- Coordinate with research sponsors or CROs, local or central IRBs, Research and Development, and ancillary departments to support protocol implementation and ongoing study maintenance.
- Monitor enrollment goals and implement action plans as needed.
- Coordinate informed consents, screening materials, study visits, and communication between participants and the research study team.
- Collect study data from patient charts, medical records, interviews, questionnaires, diagnostic tests, and other sources.
- Collect, process, and ship research specimens as directed by the protocol.
- Ensure compliance with study protocols and regulatory agency requirements.
- Track and report adverse events and protocol deviations.
- Coordinate site monitoring and auditing visits by sponsors or federal agencies during studies and at closure.
- Prepare, submit, and maintain IRB, R&D, FDA, funding, and other regulatory documents and research correspondence.
- Develop and maintain patient databases and study logs, including training, delegation of responsibility, screening, enrollment, and investigational product logs.
- Manage multiple complex studies and significant workload.
- Provide clinical research training and mentorship to junior and intermediate CRCs.
- Contribute to trial planning, development, and implementation.
- Provide education and support to research team members and ancillary departments involved in research.
- Assist with protocol feasibility assessments, identify potential barriers, and proactively solve problems.
- Assist in developing data collection systems and compiling study-related reports.
- Assist in writing research grant proposals, manuscripts, study materials, brochures, and correspondence.
- Act as a champion for clinical research at Carilion Clinic.
Benefits
- Comprehensive medical, dental, and vision benefits.
- Employer-funded pension plan, vested after five years.
- Voluntary 403B.
- Paid time off accrued from day one.
- Onsite fitness studios and discounts to Carilion Wellness centers.
- Access to the Personify Health health and wellness app.
- Childcare discounts.
- Continued education and training.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
