Senior Clinical Research Coordinator - M Dougan Lab

About the role

The CRC works within the clinical research program and supports 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 is responsible for the primary data collection and management of patient clinical information as it pertains to participation in clinical trials. They ensure timely facilitation of trial assessments per protocol and collection of protocol related samples including shipment to outside entities as required. They support and maintain participant/subject trial binders and may maintain regulatory binders to ensure study compliance with all state, federal, and IRB requirements. They 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.

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 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
• Coordinate and manage 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

Requirements

Knowledge, Skills, And Abilities Required:

• 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
• Able to effectively manage time and prioritize workload
• Practice discretion and always adhere to hospital confidentiality guidelines
• Have computer skills including the use of Microsoft Office

Qualifications

• The position requires a bachelor's degree or 3 years of experience as a Dana-Farber Clinical Research Coordinator.
• Additionally, 3-5 years of equivalent experience is required, with preference for candidates who have worked in a medical, scientific research, or technology-oriented business environment.

Supervisory Responsibilities

Provides day-to-day work direction to CRC I and II. Assists Clinical Research Managers with completion of performance reviews and provides input as needed for development and corrective action activities.

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.