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Dana-Farber Cancer Institute · 5 hours ago

Regulatory Coordinator - Breast Oncology

Boston, MA

Full-time

Hybrid

New Grad, Entry Level

$56K/yr - $62K/yr

0+ years exp

Dana-Farber Cancer Institute is a leader in cancer research and patient care, and they are seeking a Regulatory Coordinator to support the regulatory requirements of clinical research projects in Breast Oncology. The role involves coordinating protocol submissions, maintaining regulatory compliance, and collaborating with various stakeholders in the clinical trials process.

CommunitiesHealth CareHealth DiagnosticsHospitalNon ProfitOncology

Responsibilities

Prepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval

Prepares and submits regulatory documentation that may include IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies including the Food and Drug Administration (FDA), Office of Biotechnology Activities (OBA), etc

Prepares, maintains and organizes Regulatory files for each assigned study in compliance with study sponsor requirement; Industry sponsor, DF/HCC sponsored etc

Maintains various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion

Assists in the preparation and coordination of assigned study monitoring and auditing visits with study coordinator, Investigator, DF/HCC ODQ, Industry Sponsors, and third-party auditors

Track and manage assigned new protocol start-up packet; initiate, facilitate, and monitor study start-up progress to ensure established benchmarks are met

Communicate and collaborate with clinical trial key stakeholders through the start-up process, provide regular updates and ensure all start-up activities are completed

Create and maintain tracking for all subsequent submissions to the SRC/IRB; protocol & consent amendments, all required safety reporting, all required deviation, violation, exception, or other event reporting. Ensure various regulatory reporting required are met, Study Sponsor, FDA, IRB etc

Establishing and maintaining regular communication with study team, study sponsor, applicable regulatory agencies / offices to ensure all required information is relayed and responsible for the systematic documentation / tracking when applicable

Serve as facilitator for study team and sponsor regarding study status information, critical safety issues, upcoming protocol, consent and IDB amendments and applicable protocol training; responsible for the systematic documentation / tracking when applicable

Maintain working knowledge of current regulations, regulatory guidance and or local policies

Assists Clinical research Manager with regulatory based training and implementation of new or revised regulation, guidance and or local policy

Present regulatory status for disease group portfolio at applicable research meetings

Qualification

Regulatory complianceClinical trial knowledgeMicrosoft applicationsMedical terminologyWritten communicationOral communicationAttention to detailTime management