Regulatory Coordinator II - Breast Cancer Center

Regulatory Compliance 

• 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 QACT, Industry Sponsors, and third party auditors.

Clinical Trial Management 

• 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. 

Key Stakeholder Interfacing 

• 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 with regard to study status information, critical safety issues, upcoming protocol, consent and IDB amendments and applicable protocol training; responsible for the systematic documentation / tracking when applicable 

Leadership and Professionalism 

• 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 

• Bachelor's degree (BA, BS) in life sciences, nursing, or other related discipline is required; 1-3 years of direct regulatory experience required.
• Must have intermediate / very proficient knowledge of FDA and ICH/GCP guidelines.
• Previous experience with clinical trials and/or research coordination required. 
• Must possess excellent written and oral communication skills, maintain confidentiality of information, demonstrate good decision-making and judgment and have attention to detail and follow-through skills.
• Demonstrated organization and time management/prioritization skills with the ability to work independently are required.
• Must be proficient in the use of computers, Microsoft applications and databases.
• Requires experience with medical terminology.

Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.