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Dana-Farber Cancer Institute · 10 hours ago

Clinical Research Coordinator - Breast Oncology Cohort Studies Program

Boston, MA

Full-time

Onsite

New Grad, Entry Level

$48K/yr - $54K/yr

0+ years exp

Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. The Clinical Research Coordinator will support the Breast Oncology Cohort Studies Program, managing clinical trials, data collection, and patient interaction to ensure high-quality research outcomes.

CommunitiesHealth CareHealth DiagnosticsHospitalNon ProfitOncology

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

Qualification

Clinical Trial ManagementData ManagementBiospecimen CollectionRegulatory SubmissionsMicrosoft OfficeCommunication SkillsInterpersonal SkillsDetail OrientedTime Management