Job Description

Clinical Research Coordinator II

Job Description

• Screens and evaluates potential patients for protocol eligibility, presents study details, and facilitates the informed consent and enrollment process.
• Coordinates patient care in accordance with study protocols, including investigational product administration, patient education, and drug accountability.
• In collaboration with physicians, monitors patients for changes in condition, adverse events, concomitant medications, protocol compliance, and response to study treatment, ensuring accurate and thorough documentation.
• Maintains responsibility for timely and accurate data collection, entry, and reporting.
• Coordinates and participates in monitoring and audit activities, and maintains regulatory documentation in compliance with SOPs and applicable regulations.
• Participates in ongoing training and education, and supports the education of clinic staff on clinical research processes.
• May collaborate with the Research Site Leader on study selection and work directly with sponsors or external research organizations.
• Identifies quality and performance improvement opportunities and partners with staff to implement action plans.
• May be responsible for tracking and reporting protocol activity, enrollment metrics, and research-related financial data to leadership and physicians.
• Supports protocol compliance by assisting with order review and communicating study requirements, dose modifications, and adverse event reporting to physicians.
• Ensures a safe environment for patients, families, and staff by adhering to all federal, state, and professional regulatory standards, including OSHA and CDC guidelines.
• Maintains strict patient confidentiality in accordance with HIPAA and applicable laws.

Qualifications

• Associate’s degree in a clinical or scientific discipline required; Bachelor’s degree preferred
• Minimum of five years of experience in a clinical or scientific setting
• SoCRA or ACRP certification preferred

OR

• Graduate of an accredited nursing program (BSN preferred)
• Minimum of three years of nursing experience
• Prior clinical research experience preferred
• Current RN license in the state of practice
• Current BLS or ACLS certification required
• OCN, SoCRA, or ACRP certification preferred

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