Senior Clinical Research Coordinator

About the role

Lead and independently manage complex industry-sponsored clinical trials from study start-up through closeout. Coordinate complex study visit schedules and protocol-related activities while ensuring compliance with study timelines and regulatory requirements. Lead patient recruitment and retention initiatives to support enrollment performance and patient engagement goals. Mentor and support junior coordinators and research staff on clinical trial processes, patient interactions, sponsor communication, and operational best practices. Conduct protocol-required patient visits and assessments in accordance with study protocols, GCP guidelines, and site SOPs. Perform protocol-required clinical procedures including vital signs, ECGs, specimen collection, investigational product accountability, and phlebotomy, as permitted by applicable regulations, training, and organizational policy. Process laboratory specimens and prepare shipments in accordance with protocol requirements and applicable IATA regulations. Maintain accurate and timely study documentation including source records, informed consent forms, CTMS updates, and case report forms. Ensure high-quality data entry and timely resolution of sponsor and CRO data queries. Serve as a primary point of contact for study participants, sponsors, CROs, investigators, and site leadership. Build strong relationships with investigators, referring physicians, sponsors, and CRO partners to support study success and patient engagement. Prepare for and support sponsor, CRO, and regulatory monitoring visits, audits, and inspections. Review safety reports and ensure timely investigator review and documentation. Maintain inventory and oversight of study equipment, supplies, and investigational products onsite. Assess operational challenges, identify solutions, and recommend process improvements to enhance site performance and protocol adherence. Support site performance initiatives related to enrollment, screen failures, protocol compliance, and patient retention. Contribute to onboarding, training, and mentorship activities for new research staff. Support the protection of human research participants in compliance with federal regulations, GCP, HIPAA, and institutional policies. Maintain compliance with all site SOPs, privacy standards, and research protocols.

Responsibilities

• Lead and independently manage complex industry-sponsored clinical trials from study start-up through closeout.
• Coordinate complex study visit schedules and protocol-related activities while ensuring compliance with study timelines and regulatory requirements.
• Lead patient recruitment and retention initiatives to support enrollment performance and patient engagement goals.
• Mentor and support junior coordinators and research staff on clinical trial processes, patient interactions, sponsor communication, and operational best practices.
• Conduct protocol-required patient visits and assessments in accordance with study protocols, GCP guidelines, and site SOPs.
• Perform protocol-required clinical procedures including vital signs, ECGs, specimen collection, investigational product accountability, and phlebotomy, as permitted by applicable regulations, training, and organizational policy.
• Process laboratory specimens and prepare shipments in accordance with protocol requirements and applicable IATA regulations.
• Maintain accurate and timely study documentation including source records, informed consent forms, CTMS updates, and case report forms.
• Ensure high-quality data entry and timely resolution of sponsor and CRO data queries.
• Serve as a primary point of contact for study participants, sponsors, CROs, investigators, and site leadership.
• Build strong relationships with investigators, referring physicians, sponsors, and CRO partners to support study success and patient engagement.
• Prepare for and support sponsor, CRO, and regulatory monitoring visits, audits, and inspections.
• Review safety reports and ensure timely investigator review and documentation.
• Maintain inventory and oversight of study equipment, supplies, and investigational products onsite.
• Assess operational challenges, identify solutions, and recommend process improvements to enhance site performance and protocol adherence.
• Support site performance initiatives related to enrollment, screen failures, protocol compliance, and patient retention.
• Contribute to onboarding, training, and mentorship activities for new research staff.
• Support the protection of human research participants in compliance with federal regulations, GCP, HIPAA, and institutional policies.
• Maintain compliance with all site SOPs, privacy standards, and research protocols.

Requirements

• Associate’s or Bachelor’s degree in a scientific, healthcare, or related discipline required.
• 5+ years of clinical research or healthcare experience required.
• Must be able to perform blood draw, medical review (blood pressure, height, weight etc.) & EKGs, as applicable by state law.
• Experience in [gastroenterology, hepatology, cardiology] therapeutic areas preferred.
• CCRC® — Certified Clinical Research Coordinator or CCRP® — Certified Clinical Research Professional or equivalent clinical research certification strongly preferred.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Demonstrated ability to independently manage complex clinical trials and competing priorities.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong understanding of GCP, FDA regulations, and clinical research operations.
• Strong