Clinical Research Coordinator

Position Summary:

The Clinical Research Coordinator (CRC) is an experienced, independent clinical execution role responsible for managing complex study activities, ensuring protocol compliance and data integrity, and serving as a senior resource within the site team. Reporting to the Site Manager and working closely with the Associate Director, Site Development, the CRC leads the full lifecycle of clinical trial conduct across multiple concurrent studies — from site activation and patient enrollment through study close-out. The CRC II serves as a mentor and functional lead for Junior staff, and partners with Regulatory, Patient Engagement, Commercial Strategy, and Site Operations teams to ensure CTR executes studies with precision and in full compliance with GCP, IRB, and sponsor requirements.

Key Responsibilities:

Patient Enrollment & Study Conduct

• Lead patient screening, eligibility assessment, and enrollment activities across multiple concurrent protocols, exercising independent clinical judgment on complex eligibility determinations.
• Oversee informed consent processes, ensuring full compliance with IRB-approved consent procedures and documenting exceptions or deviations appropriately.
• Perform and/or supervise all study visit activities including dosing, drug administration, drug accountability, specimen collection and shipping, CTMS data entry, and patient record maintenance.
• Monitor study activities for ongoing compliance with protocols, ICH-GCP standards, and applicable regulatory requirements; proactively identify and escalate compliance risks.
• Track and manage enrollment status across assigned studies; document patient dropouts; record, report, and follow up on adverse events and protocol deviations in accordance with sponsor and regulatory requirements.
• Serve as the primary site contact for sponsor representatives and CROs during monitoring visits and routine study communications.

Data Quality & Regulatory Compliance

• Create, maintain, and quality-review source documents and study records in accordance with GCP, CTR SOPs, and sponsor requirements.
• Build, manage, and audit study data in CTMS (RealTime), ensuring timely, accurate, and complete data entry across all active studies; identify and resolve data discrepancies prior to monitoring visits.
• Adhere to all applicable SOPs, ICH-GCP guidelines, HIPAA requirements, and privacy regulations at all times.
• Lead preparation for internal audits, sponsor monitoring visits, and regulatory inspections; serve as the primary point of contact for on-site monitors and ensure inspection-ready study files are maintained continuously.
• Review and contribute to the development and revision of CTR SOPs and study-specific procedures as requested by the Site Manager or Quality team.

Study Start-Up & Business Development Support

• Lead or co-lead site activation activities including IRB submissions, protocol training, system setup in CTMS, and regulatory document collection.
• Complete feasibility questionnaires and support pre-award site visits, drawing on protocol-level expertise to provide accurate and competitive assessments.
• Provide clinical and protocol intelligence to the Commercial Strategy and Site Development teams to support feasibility submissions and sponsor engagement.
• Assist with budget and contract review by identifying protocol-driven visit and procedure requirements; escalate scope discrepancies to the Site Manager or CBO.

Team Leadership & Site Operations

• Serve as a mentor and day-to-day resource for CRC I staff and Research Assistants; provide protocol-specific training, answer procedural questions, and escalate performance concerns to the Site Manager.
• Coordinate with Patient Engagement, Regulatory & Quality, and Site Operations teams to ensure seamless patient scheduling, visit preparation, and study execution.
• Support study close-out activities including final data reconciliation, regulatory binder completion, and sponsor communication.
• Contribute to a culture of quality, accountability, and continuous improvement within the site team.

Pay: $55,000.00 - $75,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Vision insurance

Work Location: In person