Clinical Research Coordinator

About the Role

The Clinical Research Coordinator (CRC) supports the clinical research program and research team in the overall conduct of clinical trials, adhering to Good Clinical Practice under the auspices of the Principal Investigator and Clinical Research Manager. This position is open to both a CRC I and CRC II level.

Key Responsibilities

• Primary data collection and management of patient clinical information related to trial participation.
• Timely facilitation of trial assessments per protocol and collection of protocol-related samples, including shipment to outside entities as required.
• Support and maintenance of participant/subject trial binders and regulatory binders to ensure study compliance.
• Oversight of the clinical trials start-up process through Scientific Review Committee and IRB submissions, and site activation.
• Data reporting and management, including 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.
• Enter all required study data on an ongoing basis.
• Ensure all study-related samples are collected, properly prepared, and shipped according to protocol requirements and IATA/DOT regulations.
• Collaborate with other departments such as Protocol Scheduling, Materials Management, Clinical Research Laboratory, Pharmacy, and Research Nursing.
• Organize and prepare for 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.
• Interact with study participants as directed/required by the protocol and/or study team.
• May be responsible for tissue sample collection per trial requirements.
• Data entry of Subject Visit Tracking information into Clinical Trial Management System contemporaneously with medical visits.
• Data entry of time and effort spent on study-specific activities into Clinical Trial Management System contemporaneously with work completed.
• Data entry of study-specific activity into Clinical Trial Management System contemporaneously with activity completed.
• May distribute protocol schedules, quality of life surveys, subject diaries, and/or conduct follow-up communication with patients.

Potential Responsibilities (May be responsible for)

• Pertinent IRB protocol submissions.
• Obtain informed consent for non-treatment trials.
• Screen patients for protocol eligibility.
• Prepare and/or complete regulatory-related reports and IRB submissions.

Requirements & Tech Stack

• Good Clinical Practice
• ONCORE (Clinical Trials Management System)
• Clinical Trial Management System (General)
• Microsoft Office
• IATA/DOT regulations

Qualifications

• Bachelor’s Degree or 1 year of Dana-Farber Associate Clinical Research Coordinator experience required.
• 0-1 years of experience working in a medical or scientific research setting or comparable technology-oriented business environment preferred.
• Excellent organization and communication skills.
• Strong interpersonal skills – ability to effectively interact with all levels of staff and external 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.
• Computer skills.
• May have contact with Adult and Pediatric patients of all ages and populations.

Some travel may be required.