Clinical Research Coordinator – Adult Leukemia Trials

Dana-Farber Cancer Institute; Boston (MA); On-site; USD 48,000 - 54,000; Full time

Job summary

The Clinical Research Coordinator (CRC) at Dana-Farber Cancer Institute will support the adult Leukemia clinical research program, ensuring data collection and trial conduct under GCP, PI, and the Clinical Research Manager.

Responsibilities include data management, regulatory binder maintenance, IRB submissions, patient screening, informed consent, ONCORE registration, and occasional sample shipment. Some travel may be required.

Qualifications

• Bachelor's degree or 1 year Dana-Farber Associate Clinical Research Coordinator experience required.
• 0–1 years of experience working in a medical or scientific research setting or comparable technology orientated business environment preferred.

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.
• May 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.
• Responsible for organizing and preparing 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.
• Responsible for data entry of Subject Visit Tracking information into Clinical Trial Management System contemporaneously with medical visits, assessments, and other subject-specific information.
• Responsible for data entry of time and effort spent on study-specific activities and other administrative tasks into Clinical Trial Management System contemporaneously with work completed.
• Responsible for data entry of study-specific activity, including but not limited to monitor visits, external site enrollment, amendments, receipt of Safety Reports, etc. into Clinical Trial Management System contemporaneously with activity completed.

Skills

Organizational skills

Interpersonal skills

Attention to detail

Time management

Discretion

Microsoft Office

Education

Bachelor's degree or Dana-Farber CRC experience

Job description

The Clinical Research Coordinator (CRC) at Dana-Farber Cancer Institute will support the adult Leukemia clinical research program, ensuring data collection and trial conduct under GCP, PI, and the Clinical Research Manager.

Responsibilities include data management, regulatory binder maintenance, IRB submissions, patient screening, informed consent, ONCORE registration, and occasional sample shipment. Some travel may be required.