Senior Clinical Research Coordinator

Where You’ll Drive Impact

• 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
• Perform job related duties as requested

What You Bring to the Team

• 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
• 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
• Experience mentoring or supporting junior research staff
• Strong written and verbal communication skills
• Strong organizational skills, attention to detail, and problem-solving capabilities
• Proficiency with CTMS, EDC systems, and standard office software applications

Physical Requirements

• Ability to sit, stand, and move throughout clinical and office environments for extended periods of time
• Ability to lift and move up to 25 pounds as needed