Sr. Clinical Research Coordinator

The Sr Clinical Research Coordinator is responsible for the day-to-day management and coordination of clinical trials from study startup through closeout. This individual will serve as a key resource for investigators, sponsors, and study teams while ensuring compliance with protocol requirements, Good Clinical Practice (GCP), federal regulations, and institutional policies.

The ideal candidate is a proactive research professional who can independently manage multiple studies, mentor junior team members, and thrive in a fast-paced academic environment.

Key Responsibilities

• Coordinate all aspects of clinical trial operations, including startup, enrollment, maintenance, and closeout activities
• Screen, recruit, consent, and enroll study participants
• Conduct study visits and ensure protocol adherence
• Maintain accurate source documentation and electronic regulatory binders
• Manage IRB submissions, amendments, continuing reviews, and study correspondence
• Prepare for sponsor, FDA, and internal audits/inspections
• Serve as the primary point of contact for sponsors, CROs, and investigators
• Track subject enrollment, study milestones, and timelines
• Monitor study budgets and research-related expenses
• Review and resolve data queries within electronic data capture (EDC) systems
• Coordinate specimen collection, processing, and shipment when required
• Assist with training and mentorship of junior research staff
• Ensure compliance with GCP, ICH guidelines, HIPAA, and applicable regulations

Qualifications

Required

• Bachelor's degree in a scientific, healthcare, or related field
• Minimum 3+ years of clinical research coordination experience
• Experience managing clinical trials independently
• Strong understanding of GCP, FDA regulations, and IRB processes
• Experience with patient recruitment, consenting, and study management
• Excellent organizational, communication, and project management skills
• Ability to manage multiple priorities in a deadline-driven environment

Preferred

• Experience working within an academic medical center, hospital system, or research institution
• Oncology, cardiology, neurology, rare disease, or other complex therapeutic area experience
• CCRC, CCRP, or equivalent professional certification
• Experience supporting multi-site or industry-sponsored clinical trials
• Knowledge of EDC systems such as Medidata Rave, REDCap, or similar platforms