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)
