Dana-Farber Cancer Institute
Regulatory Coordinator - GU Oncology
Dana-Farber Cancer Institute, Boston, Massachusetts, us, 02298
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Regulatory Coordinator - GU Oncology
role at
Dana-Farber Cancer Institute
The Regulatory Coordinator (RC) works under the direction of the Principal Investigator(s) and the Regulatory Operations Manager 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 regulation and ICH/GCP guidelines. This position will work collaboratively 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. The RC 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.
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, educate tomorrow’s physicians and researchers, and work with amazing partners, including other Harvard Medical School‑affiliated hospitals.
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. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. If working in this kind of organization inspires you, we encourage you to apply.
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 requirements; 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 packets; 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 and 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 or offices to ensure all required information is relayed and responsible for systematic documentation and 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 systematic documentation and tracking when applicable.
Leadership and Professionalism
Maintain working knowledge of current regulations, regulatory guidance and local policies.
Assist clinical research manager with regulatory‑based training and implementation of new or revised regulation, guidance and local policy.
Present regulatory status for disease group portfolio at applicable research meetings.
Bachelor’s degree required.
0–1 year of 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 described above with regular and ongoing training and supervision.
Attain and demonstrate fundamental knowledge and be somewhat proficient in areas such as DFCI, DF/HCC, ICH/GCP, FDA policy, guidance, and regulation; understanding of the IRB submission and approval process; regulatory binder maintenance; PI‑initiated/multi‑center trials; protocol and consent design and development; 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.
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.
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Regulatory Coordinator - GU Oncology
role at
Dana-Farber Cancer Institute
The Regulatory Coordinator (RC) works under the direction of the Principal Investigator(s) and the Regulatory Operations Manager 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 regulation and ICH/GCP guidelines. This position will work collaboratively 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. The RC 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.
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, educate tomorrow’s physicians and researchers, and work with amazing partners, including other Harvard Medical School‑affiliated hospitals.
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. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. If working in this kind of organization inspires you, we encourage you to apply.
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 requirements; 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 packets; 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 and 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 or offices to ensure all required information is relayed and responsible for systematic documentation and 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 systematic documentation and tracking when applicable.
Leadership and Professionalism
Maintain working knowledge of current regulations, regulatory guidance and local policies.
Assist clinical research manager with regulatory‑based training and implementation of new or revised regulation, guidance and local policy.
Present regulatory status for disease group portfolio at applicable research meetings.
Bachelor’s degree required.
0–1 year of 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 described above with regular and ongoing training and supervision.
Attain and demonstrate fundamental knowledge and be somewhat proficient in areas such as DFCI, DF/HCC, ICH/GCP, FDA policy, guidance, and regulation; understanding of the IRB submission and approval process; regulatory binder maintenance; PI‑initiated/multi‑center trials; protocol and consent design and development; 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.
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.
#J-18808-Ljbffr