Clinical Research Coordinator - GYN Oncology

Dana-Farber Cancer Institute
Boston

Job Description

Job ID: 23048
Date Posted: 10/25/2012
Location: Galleria
Job Family: Research
Full/Part Time: Full-Time
Regular/Temporary: Regular
FLSA Status: Nonexempt

Job Summary

Located in Boston, Dana Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow’s physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

The Division of Women’s Cancers is recruiting a Clinical Research Coordinator (CRC) to work within the Gynecologic Oncology Center (GYN) to 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 entitles 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 risks protocols).  This individual may also screen patients for protocol eligibility, obtain consent and register study participants with the Quality Assurance for Clinical Trials (QACT).

Primary Duties and 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 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.