Clinical Research Coordinator - Thoracic Oncology

About the role

The Clinical Research Coordinator (CRC) works within the Thoracic Oncology 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.

Responsibilities

• Primary data collection and management of patient clinical information as it pertains to participation in clinical trials.
• Timely facilitation of trial assessments per protocol and collection of protocol-related samples, including shipment to outside entities as required.
• Support and maintain participant/subject trial binders and regulatory binders to ensure study compliance with all state, federal, and IRB requirements.
• Oversight of the clinical trials start-up process from receipt of protocols through Scientific Review Committee and IRB submissions, and site activation activities.
• 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.
• 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, Research Nursing, and others as needed per the requirements of the clinical trial.
• Organize and prepare for both internal and external auditing and study monitoring visits.
• 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.
• Data entry of Subject Visit Tracking information, time and effort spent on study-specific activities, and other administrative tasks into the Clinical Trial Management System contemporaneously with work completed.
• Data entry of study-specific activity, including monitor visits, external site enrollment, amendments, receipt of Safety Reports, etc., into the Clinical Trial Management System contemporaneously with activity completed.

Requirements

• Excellent organization and communication skills.
• Strong interpersonal skills – ability to effectively interact with all levels of staff and external contacts.
• Detail-oriented with the ability to follow through.
• Ability to effectively manage time and prioritize workload.
• Must practice discretion and adhere to hospital confidentiality guidelines.
• Computer skills including the use of Microsoft Office.

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.

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

$48,100.00 - $54,400.00