Dana-Farber Cancer Institute
Regulatory Coordinator I
Dana-Farber Cancer Institute, Brookline, Massachusetts, us, 02445
The Regulatory Coordinator (RC) works under the direction of the Principal Investigator(s), 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 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. 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, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
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
Tracks and manages assigned new protocol start-up packet; initiates, facilitates, and monitors study start-up progress to ensure established benchmarks are met.Communicates and collaborates with clinical trial key stakeholders through the start-up process, provides regular updates, and ensures all start-up activities are completed.Creates and maintains 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. Ensures various regulatory reporting required are met; Study Sponsor, FDA, IRB, etc.
Key Stakeholder Interfacing
Establishes and maintains regular communication with study team, study sponsor, applicable regulatory agencies/offices to ensure all required information is relayed and is responsible for the systematic documentation/tracking when applicable.Serves 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.
Leadership and Professionalism
Maintains working knowledge of current regulations, regulatory guidance, and local policies.Assists Clinical Research Manager with regulatory-based training and implementation of new or revised regulations, guidance, and local policy.Presents 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 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. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.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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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
Tracks and manages assigned new protocol start-up packet; initiates, facilitates, and monitors study start-up progress to ensure established benchmarks are met.Communicates and collaborates with clinical trial key stakeholders through the start-up process, provides regular updates, and ensures all start-up activities are completed.Creates and maintains 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. Ensures various regulatory reporting required are met; Study Sponsor, FDA, IRB, etc.
Key Stakeholder Interfacing
Establishes and maintains regular communication with study team, study sponsor, applicable regulatory agencies/offices to ensure all required information is relayed and is responsible for the systematic documentation/tracking when applicable.Serves 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.
Leadership and Professionalism
Maintains working knowledge of current regulations, regulatory guidance, and local policies.Assists Clinical Research Manager with regulatory-based training and implementation of new or revised regulations, guidance, and local policy.Presents 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 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. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.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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