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Position Summary

The Clinical Research Coordinator (CRC) is responsible for coordinating and managing clinical research studies while ensuring compliance with study protocols, Good Clinical Practice (GCP), FDA regulations, and site Standard Operating Procedures (SOPs). This role works closely with investigators, sponsors, contract research organizations (CROs), study participants, and internal teams to support the successful execution of clinical trials.

The ideal candidate is organized, detail-oriented, able to manage multiple priorities, and committed to providing an exceptional experience for study participants while maintaining the highest standards of research quality and compliance. Placement at the CRC I, II, or III level will be based on the candidate's education, experience, and demonstrated competencies.

Essential Responsibilities

• Coordinate and manage day-to-day activities for assigned clinical research studies.
• Ensure studies are conducted in accordance with study protocols, GCP, FDA regulations, IRB requirements, and site SOPs.
• Coordinate participant visits, including informed consent, study procedures, and follow-up activities.
• Complete accurate and timely source documentation and data entry into electronic data capture (EDC) systems.
• Maintain study regulatory documents, logs, and essential study records.
• Coordinate laboratory specimen collection, processing, storage, and shipment.
• Maintain investigational product accountability, including receipt, storage, dispensing, reconciliation, and documentation.
• Document and report adverse events in accordance with protocol and regulatory requirements.
• Serve as the primary point of contact for sponsors, monitors, CROs, laboratories, and study participants.
• Coordinate monitoring visits, site initiation visits, and study closeout activities.
• Maintain study supplies and coordinate ordering as needed.
• Collaborate with investigators and research staff to ensure participant safety and protocol compliance.
• Support quality assurance activities, audits, and regulatory inspections.
• Participate in study-specific training and investigator meetings.
• Contribute to a positive, collaborative, and patient-focused research environment.
• Perform other duties as assigned.

Preferred Qualifications

• High school diploma or GED required; Associate's or Bachelor's degree in a science or healthcare-related field preferred.
• Approximately 2–5 years of clinical research coordination experience preferred; candidates with less or more experience are encouraged to apply.
• Experience coordinating industry-sponsored clinical trials preferred.
• Working knowledge of GCP, FDA regulations, ICH guidelines, and human subject protection requirements.
• Experience with EDC systems and electronic regulatory systems preferred.
• CCRC or CCRP certification is preferred but not required.

Knowledge, Skills, and Abilities

• Excellent organizational and time-management skills.
• Strong written and verbal communication skills.
• Ability to prioritize multiple studies and competing deadlines.
• Strong attention to detail and commitment to data quality.
• Ability to work independently while collaborating effectively with multidisciplinary teams.
• Professional judgment, initiative, and problem-solving skills.
• Proficiency with Microsoft Office and clinical research software.

Physical Requirements

• Ability to work onsite during standard business hours.
• Ability to occasionally lift up to 15 pounds.