Clinical Research Coordinator II - Breast Oncology

Overview

The CRC (Clinical Research Coordinators) work within the Breast Oncology 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 and the Clinical Research Manager. 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 facilitation of trial assessments per protocol and collection of protocol related samples including shipment to outside entities as required. Will support and maintain participant/subject trial binders and may maintain regulatory binders, to ensure study compliance with all state, federal, and IRB requirements. May be responsible for pertinent IRB protocol submissions.

This individual may also screen patients for protocol eligibility, obtain informed consent for non-treatment trials, and register study participants with the clinical trials management system, ONCORE. Some travel may be required.

Oversight

Oversee the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities.

Responsibilities

• 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
• Maintain and organize study participant/subject trial binder and regulatory binders, enter all required study data on an ongoing basis and as applicable
• Ensure all study related samples are collected, properly prepared, and shipped according to the protocol requirements and IATA/DOT regulations
• Collaborate with other departments such as Protocol Scheduling, Materials Management, the Clinical Research Laboratory, Pharmacy, Research Nursing, and other departments, as needed per the requirements of the clinical trial
• Organize and prepare for both internal and external auditing and study monitoring visits
• Coordination and management of clinical trials throughout the trial life cycle, 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 collection per trial requirements

Qualifications

• The position requires a bachelor's degree or 2 years of experience as a Dana-Farber Clinical Research Coordinator. Candidates should have 1-3 years of relevant experience, with a preference for those with a background in medical or scientific research or a technology-oriented business environment.

Supervisory Responsibilities

Orients and assists in training new staff.

Patient Contact

May have contact with Adult and Pediatric patients of all ages and populations. May distribute protocol schedules, quality of life surveys or other study-related questionnaires, subject diaries, and/or conduct follow-up communication with patients.

Pay

$56,000.00 - $63,700.00