Dana-Farber Cancer Institute
Regulatory Coordinator - Breast Oncology
Dana-Farber Cancer Institute, Boston, Massachusetts, us, 02298
Regulatory Coordinator - Breast Oncology
Join to apply for the
Regulatory Coordinator - Breast Oncology
role at
Dana-Farber Cancer Institute . The
Regulatory Coordinators (RC)
work under the direction of the Breast Oncology Principal Investigator(s), Regulatory Operations Manager, Clinical Research Manager, and/or directly for the Clinical Trials Office to complete the regulatory requirements of the clinical research project. The RC coordinates aspects of protocol submissions, prepares and submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal regulations and ICH/GCP guidelines. This position will collaborate with a variety of personnel at all levels, including faculty and study team members of DF/HCC and external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations. Works interactively with the Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the various DF/HCC institutions. Location and Remote Work
- This position is 100% remote off-site. The selected candidate must reside and work remotely in a New England state (MA, ME, NH, CT, RI, VT). Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life-changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health—particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with partners, including Harvard Medical School-affiliated hospitals. Regulatory Compliance Prepares and submits protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval. Prepares and submits regulatory documentation such as IND/IDE applications, FDA annual reports, Serious Adverse Event reports to appropriate regulatory agencies. Prepares, maintains, and organizes regulatory files for each assigned study in compliance with sponsor requirements. Maintains 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 packets; initiate, facilitate and monitor start-up progress to ensure established benchmarks are met. Communicate and collaborate with clinical trial 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 and consent amendments, all required safety reporting, all required deviation, violation, exception or other event reporting. Ensure regulatory reporting requirements are met (Sponsor, FDA, IRB). Key Stakeholder Interfacing Establish and maintain regular communication with study teams, study sponsors, applicable regulatory agencies/offices to ensure all required information is relayed and responsible for systematic documentation/tracking when applicable. Serve as facilitator for study team and sponsor with regard to study status information, critical safety issues, upcoming protocol 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 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 required. Experience working in a medical or scientific research setting or comparable technology oriented business environment preferred. Fundamental knowledge of the conduct of clinical trials is preferred. Required Competencies Must be able to perform day to day responsibilities duties as described above with regular and ongoing training and supervision. Attains and can demonstrate fundamental knowledge and is somewhat proficient in some or all of the following areas: DFCI, DF/HCC, ICH/GCP, FDA policy / guidance / regulation; an understanding of the IRB submission & approval process; Regulatory Binder maintenance; PI Initiated / Multi-Center Trials; protocol and consent design and development and FDA IND and other regulatory required submissions. Knowledge, Skills, And Abilities 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. At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. We are committed to diversifying our faculty and staff and to hiring dedicated and diverse professionals. 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 characteristics protected by law. EEOC Poster
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Join to apply for the
Regulatory Coordinator - Breast Oncology
role at
Dana-Farber Cancer Institute . The
Regulatory Coordinators (RC)
work under the direction of the Breast Oncology Principal Investigator(s), Regulatory Operations Manager, Clinical Research Manager, and/or directly for the Clinical Trials Office to complete the regulatory requirements of the clinical research project. The RC coordinates aspects of protocol submissions, prepares and submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal regulations and ICH/GCP guidelines. This position will collaborate with a variety of personnel at all levels, including faculty and study team members of DF/HCC and external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations. Works interactively with the Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the various DF/HCC institutions. Location and Remote Work
- This position is 100% remote off-site. The selected candidate must reside and work remotely in a New England state (MA, ME, NH, CT, RI, VT). Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life-changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health—particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with partners, including Harvard Medical School-affiliated hospitals. Regulatory Compliance Prepares and submits protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval. Prepares and submits regulatory documentation such as IND/IDE applications, FDA annual reports, Serious Adverse Event reports to appropriate regulatory agencies. Prepares, maintains, and organizes regulatory files for each assigned study in compliance with sponsor requirements. Maintains 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 packets; initiate, facilitate and monitor start-up progress to ensure established benchmarks are met. Communicate and collaborate with clinical trial 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 and consent amendments, all required safety reporting, all required deviation, violation, exception or other event reporting. Ensure regulatory reporting requirements are met (Sponsor, FDA, IRB). Key Stakeholder Interfacing Establish and maintain regular communication with study teams, study sponsors, applicable regulatory agencies/offices to ensure all required information is relayed and responsible for systematic documentation/tracking when applicable. Serve as facilitator for study team and sponsor with regard to study status information, critical safety issues, upcoming protocol 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 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 required. Experience working in a medical or scientific research setting or comparable technology oriented business environment preferred. Fundamental knowledge of the conduct of clinical trials is preferred. Required Competencies Must be able to perform day to day responsibilities duties as described above with regular and ongoing training and supervision. Attains and can demonstrate fundamental knowledge and is somewhat proficient in some or all of the following areas: DFCI, DF/HCC, ICH/GCP, FDA policy / guidance / regulation; an understanding of the IRB submission & approval process; Regulatory Binder maintenance; PI Initiated / Multi-Center Trials; protocol and consent design and development and FDA IND and other regulatory required submissions. Knowledge, Skills, And Abilities 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. At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. We are committed to diversifying our faculty and staff and to hiring dedicated and diverse professionals. 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 characteristics protected by law. EEOC Poster
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