Clinical Research Coordinator - GI Oncology

Dana-Farber Cancer Institute • Boston, MA

139d

About The Position

The Gastrointestinal (GI) Oncology Clinical Research Program at Dana-Farber Cancer Institute is seeking a Clinical Research Coordinator (CRC) to join the clinical research team. The GI Oncology Clinical Research Program supports PI initiated, industry sponsored, and cooperative group phase I - IV clinical trials across multiple GI cancers, including esophageal, stomach, liver, pancreas, colon, and neuroendocrine. The Clinical Research Coordinator works within the clinical research program and support the 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, with 0-1 years of related experience preferred.
• Experience working in a medical or scientific research setting or comparable technology orientated business environment preferred.
• Excellent organization and communications skills required.
• Strong interpersonal skills – ability to effectively interact with all levels of staff and externals contacts.
• Must be detail oriented and have the ability to follow-through.
• Ability to effectively manage time and prioritize workload.
• Must practice discretion and adhere to hospital confidentiality guidelines at all times.
• Must have computer skills including the use of Microsoft Office.

Responsibilities

• Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities.
• Responsible for data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing and archiving of study records, and resolution of data queries.
• Prepare and or complete regulatory related reports and IRB submissions.
• Maintain and organize study regulatory binders, enter all required study data on an ongoing basis.
• Ensure all study related samples are collected, properly prepared and shipped according to the protocol requirements and IATA/DOT regulations.
• Responsible for organizing and preparing for both internal and external auditing and study monitoring visits.
• Coordination and management of clinical trials, including communication with Sponsors and regulatory authorities.
• Close-out of clinical trials, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved.
• Interact with study participants as directed/required by the protocol and/or study team.
• May be responsible for tissue sample work.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees