Regulatory Coordinator - Breast Oncology

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.ResponsibilitiesPrepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approvalPrepares 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), etcPrepares, maintains and organizes Regulatory files for each assigned study in compliance with study sponsor requirement; Industry sponsor, DF/HCC sponsored etcMaintains various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completionAssists in the preparation and coordination of assigned study monitoring and auditing visits with study coordinator, Investigator, DF/HCC ODQ, Industry Sponsors, and third-party auditorsTrack and manage assigned new protocol start-up packet; initiate, facilitate, and monitor study start-up progress to ensure established benchmarks are metCommunicate and collaborate with clinical trial key stakeholders through the start-up process, provide regular updates and ensure all start-up activities are completedCreate 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 etcEstablishing 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 applicableServe 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 applicableMaintain working knowledge of current regulations, regulatory guidance and or local policiesAssists Clinical research Manager with regulatory based training and implementation of new or revised regulation, guidance and or local policyPresent regulatory status for disease group portfolio at applicable research meetingsSkillsBachelor's degree or 1 year of experience as a Dana-Farber Associate Regulatory CoordinatorExcellent written and oral communication skillsMaintain confidentiality of informationGood decision-making and judgmentAttention to detail and follow-through skillsDemonstrated organization and time management/prioritization skillsAbility to work independentlyProficient in the use of computers, Microsoft applications and databasesExperience with medical terminologyMaintain working knowledge of current regulations, regulatory guidance and or local policies0-1 years of experience in a medical, scientific research, or technology-oriented business environmentBasic understanding of clinical trial conductCompany OverviewDana-Farber Cancer Institute is a center dedicated to carrying out adult and pediatric cancer treatment activities and advanced research. It was founded in 1947, and is headquartered in Boston, Massachusetts, USA, with a workforce of 1001-5000 employees. Its website is http://www.dana-farber.org.



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