Clinical Research Coordinator - Center of Cancer Therapeutic Innovation

Dana-Farber Cancer Institute • Boston, MA

105d

About The Position

The Clinical Research Coordinator (CRC) will work within the Center of Cancer Therapeutic Innovation (CCTI) department supporting the clinical research program and research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator. The CRC will be responsible for the primary data collection and management of patient clinical information as it pertains to participation in clinical trials. Ensures timely collection of protocol related samples including shipment to outside entities as required. Maintains regulatory binders and ensures study compliance with all state, federal, and IRB requirements. May be responsible for IRB protocol submissions (amendments, continuing reviews, and minimal risk protocols). This individual may also screen patients for protocol eligibility, obtain informed consent, and register study participants with the Quality Assurance Office for Clinical Trials (QACT). Some travel may be required.

Requirements

• Bachelor's Degree required.
• 0-1 years of related experience preferred.
• Experience working in a medical or scientific research setting or comparable technology-oriented business environment preferred.
• Excellent organization and communication skills.
• Strong interpersonal skills to interact effectively with staff and external contacts.
• Detail-oriented with the ability to follow-through.
• Ability to manage time and prioritize workload.
• Discretion and adherence to hospital confidentiality guidelines.
• Computer skills including the use of Microsoft Office.

Responsibilities

• Support the clinical research program and research team in the conduct of clinical trials.
• Collect and manage patient clinical information related to clinical trials.
• Ensure timely collection and shipment of protocol related samples.
• Maintain regulatory binders and ensure compliance with state, federal, and IRB requirements.
• Handle IRB protocol submissions including amendments and continuing reviews.
• Screen patients for protocol eligibility and obtain informed consent.
• Register study participants with the Quality Assurance Office for Clinical Trials (QACT).
• Oversee the clinical trials start-up process from protocol receipt to site activation.
• Manage data reporting and collection of source documents.
• Prepare regulatory related reports and IRB submissions.
• Organize and prepare for internal and external auditing and monitoring visits.
• Coordinate communication with Sponsors and regulatory authorities.
• Contribute to research articles and audit preparation during trial close-out.
• Interact with study participants as required by the protocol.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree