Job Description

Overview:

The Clinical Research Coordinator II (CRC II) is responsible for the day-to-day conduct and oversight of assigned clinical trials, including both administrative and regulatory functions. This role requires effective communication and collaboration with sponsors, monitors, CROs, principal investigators (PIs), and site management. The CRC II also serves as a resource for CRC Is, providing guidance on site SOPs, study protocols, and regulatory compliance. The ideal candidate demonstrates professionalism, ethical integrity, and strong problem-solving skills when addressing challenges.

Reports to: Site Manager

Key Responsibilities

• Manage daily operations and participant enrollment for assigned clinical trials in accordance with study protocols, with a focus on meeting or exceeding recruitment goals.
• Partner with the recruitment team and site leadership to develop and implement effective recruitment strategies.
• Educate patients and/or caregivers about study procedures, expectations, and potential risks or benefits.
• Monitor study progress to ensure adherence to protocols, GCP, and all applicable local, federal, and institutional regulations.
• Maintain accurate and complete e-regulatory binders and study documentation.
• Follow site policies, SOPs, and controlled documents; provide mentorship and support to CRC Is as needed.
• Schedule and coordinate study visits and monitoring activities per study timelines and sponsor requirements.
• Complete real-time source documentation during patient visits, ensuring accuracy and compliance with good documentation practices.
• Enter data into electronic data capture (EDC) systems within one business day; address data queries within 48 hours.
• Monitor and maintain inventory of study and laboratory supplies.
• Attend investigator meetings, site initiation visits, and other sponsor meetings; share updates and key information with site staff.
• Maintain thorough and organized study files, including case report forms and investigational product accountability records.
• Perform protocol-specific procedures such as vital signs, ECGs, and specimen collection.
• Communicate lab results, adverse events, and other findings promptly to investigators and document accordingly.
• Manage specimen handling, labeling, storage, and shipment in compliance with protocol requirements.
• Dispense investigational products or devices as authorized, ensuring accurate dosing and documentation.
• Identify, document, and resolve protocol deviations or unanticipated events.
• Maintain accurate investigational product (IP) accountability and ensure secure storage.
• Keep study master logs up to date, including informed consent, enrollment, delegation, and training logs.
• Participate in quality assurance and regulatory audits as needed.
• Review and track all safety reports, ensuring timely PI review and documentation.
• Uphold confidentiality of participant PHI and sponsor data at all times.
• Perform other duties as assigned.

Skills and Qualifications

• Prior experience serving as lead CRC on multiple clinical trials strongly preferred.
• Ability to work independently and collaboratively within a team environment.
• Strong mentoring and training capabilities.
• Excellent written and verbal communication skills.
• Proficiency in English (reading, writing, speaking).
• Strong knowledge of medical terminology.
• Occasional travel may be required to support or train at other research sites.

Education and Experience

• High school diploma or GED required; some college preferred.
• Minimum 2–5 years of clinical research experience required.
• Phlebotomy certification required, if applicable by state law.

Physical Requirements

• Prolonged periods of sitting and computer use.
• Must be able to lift up to 15 pounds occasionally.

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