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.

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

Skills

• Bachelor's degree or 1 year of experience as a Dana-Farber Associate Regulatory Coordinator
• Excellent written and oral communication skills
• Maintain confidentiality of information
• Good decision-making and judgment
• Attention to detail and follow-through skills
• Demonstrated organization and time management/prioritization skills
• Ability to work independently
• Proficient in the use of computers, Microsoft applications and databases
• Experience with medical terminology
• Maintain working knowledge of current regulations, regulatory guidance and or local policies
• 0-1 years of experience in a medical, scientific research, or technology-oriented business environment
• Basic understanding of clinical trial conduct

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