Clinical Research Coordinator Gastroenterology Consultants of Southwest Virginia - 5.0 Roanoke, VA Job Details Full-time $24 - $34 an hour 1 day ago Benefits Paid holidays Health insurance Dental insurance Paid time off Retirement plan Qualifications Teamwork Employee relationship building Bachelor's degree Attention to detail Organizational skills Data collection Critical thinking Microsoft 365 proficiency Full Job Description About the Company Gastroenterology Consultants of Southwest Virginia is a well-established private medical practice specializing in gastroenterology and providing comprehensive care to patients in the Southwest Virginia region. With a focus on patient-centered care and innovative treatment options, we strive to maintain excellence in clinical research and contribute to advancements in the field. Position Summary We are seeking a detail-oriented, organized, and highly motivated Clinical Research Coordinator (CRC) to join our research team. The CRC will support the successful implementation and conduct of clinical research studies while ensuring compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. This position will provide research support for a variety of IP MASH and IBD clinical trials. The CRC will work closely with Principal Investigators, the Clinical Research Manager, study sponsors, contracted vendors, and study participants to coordinate and support all aspects of clinical trial conduct. The ideal candidate will demonstrate exceptional attention to detail, strong communication and organizational skills, and the ability to effectively manage multiple priorities in a fast-paced clinical research environment. The successful candidate should be comfortable working independently, taking initiative, and contributing effectively to a collaborative research team while fostering strong working relationships with study participants, site staff, sponsors, and research partners. Responsibilities Coordinate and support the day-to-day activities of clinical research studies in accordance with study protocols, applicable regulations, and institutional policies. Assist with study start-up activities, including regulatory submissions, essential document collection, and site initiation activities. Identify, screen, and coordinate study participants according to protocol requirements. Schedule and coordinate study visits, procedures, laboratory testing, imaging, and other study-related activities. Obtain and maintain accurate and complete study documentation and source records. Enter and maintain study data in electronic data capture (EDC) systems and other study databases. Assist/Perform informed consent discussions and ensure appropriate documentation of the informed consent process. Communicate regularly with Principal Investigators, Clinical Research Manager, sponsors, CROs, monitors, and other members of the research team. Prepare for and assist with monitoring visits, audits, and regulatory inspections. Track study enrollment, participant visits, protocol-required procedures, laboratory specimens, and other study-specific activities. Identify and report protocol deviations, adverse events, and other study issues in accordance with applicable requirements. Maintain study files and essential documents in accordance with regulatory and sponsor requirements. Ensure participant confidentiality and compliance with HIPAA and other applicable privacy regulations. Foster and maintain strong working relationships with study participants, investigators, research staff, sponsors, and research partners. Participate in team meetings, investigator meetings, sponsor training, and continuing education as required. Perform other research-related duties as assigned. Qualifications Bachelor's degree in Biological Sciences or an Associate's or Bachelor's degree in Nursing required. Prior experience as a CRC in drug or medical device trials preferred. Knowledge of clinical research processes, GCP, FDA regulations, and human subject protection principles. Strong organizational skills and exceptional attention to detail. Excellent written and verbal communication skills. Ability to manage multiple studies, priorities, and deadlines effectively. Ability to work independently while also contributing effectively to a collaborative research team. Strong interpersonal skills and the ability to develop positive working relationships with participants, investigators, sponsors, and colleagues. Proficiency with Microsoft Office and the ability to learn and utilize electronic research systems and databases. Ability to maintain confidentiality and handle sensitive information appropriately. Ideal Candidate The ideal candidate is a proactive and dependable team member who takes ownership of their responsibilities and is committed to maintaining high standards of quality and accuracy. They will demonstrate strong communication skills, sound judgment, flexibility, and the ability to adapt to changing priorities in a fast-paced clinical research environment. This individual should be passionate about clinical research and committed to ensuring the safety, well-being, and positive experience of study participants while supporting the successful execution of clinical trials. Benefits Salary commensurate with experience and qualifications. Comprehensive medical and dental insurance plans. Retirement savings plans with employer matching. Paid time off and holidays. Opportunities for continuing education and professional development.

Pay:

$24.00 - $34.00 per hour

Work Location:

In person