Clinical Research Coordinator II (On-site)

Clinical Research Coordinator II (On-site)

The Clinical Research Coordinator II (CRC II) is an experienced research professional who works collaboratively with clinical research site management and the Principal Investigator (PI) to support the successful execution of clinical trials. While the PI maintains overall responsibility for the conduct of the study, the CRC II independently manages and coordinates day-to-day clinical trial activities, ensuring protocol compliance, data integrity, and operational efficiency. The CRC II also serves as a resource and mentor to research staff and contributes to study oversight, workflow optimization, and team development.

Essential Duties and Responsibilities:

• Assist the Investigator in screening and reviewing potential study participant eligibility in accordance with protocol requirements
• Maintain accurate and timely case report forms, source documentation, study charts, and regulatory documentation
• Provide mentorship, training, and day-to-day oversight to Clinical Research Coordinators and Research Assistants
• Ensure all clinical research activities are conducted in compliance with study protocols, GCP guidelines, sponsor requirements, and applicable laws, regulations, policies, and procedures
• Collect, review, and enter study data with a high degree of accuracy and attention to detail
• Support management in the candidate interview, selection, onboarding, and shadowing processes for new hires
• Assist with study start-up activities, ongoing study maintenance, and close-out procedures across assigned studies and team initiatives
• Collaborate with investigators, sponsors, CROs, and internal departments to facilitate efficient study operations and issue resolution
• Demonstrate the ability to independently prioritize workload and adapt to changing study needs and assignments
• Serve as a resource for team members regarding study processes, protocol requirements, and site procedures

Qualifications:

• Clinical Research Coordinator with 2+ years of experience
• Phlebotomy experience is highly preferred
• Excellent verbal & written communication skills
• Ability to learn quickly, read and understand complex protocols, follow very detailed directions, and multi-tasking
• Must be able to maintain strict confidentiality of patients, employees, and company information at all times and adhere to HIPAA Guidelines
• Extensive clinical trial knowledge through education and/or experience
• Successful completion of GCP Certification and Advanced CRC preferred
• Detail-oriented
• Familiarity with the Code of Federal Regulations as they pertain to human subject protection
• Strong interpersonal skills