Dana-Farber Cancer Institute
Regulatory Coordinator - Breast Oncology
Dana-Farber Cancer Institute, Boston, Massachusetts, us, 02298
Regulatory Coordinator - Breast Oncology
Be among the first 25 applicants. 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 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 interacts with the Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the various DF/HCC institutions.
Remote position with occasional on‑site time in Boston, MA. The selected candidate must reside and work remotely in a New England State (MA, ME, NH, CT, RI, VT).
Responsibilities
Prepare and submit all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval.
Prepare and submit 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.
Prepare, maintain and organize regulatory files for each assigned study in compliance with study sponsor requirements; Industry sponsor, DF/HCC sponsored etc.
Maintain various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion.
Assist 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.
Establish and maintain 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.
Assist 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.
Knowledge, Skills, and Abilities
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.
Proficient in the use of computers, Microsoft applications and databases.
Experience with medical terminology.
Minimum Job Qualifications The position requires a bachelor’s degree or 1 year of experience as a Dana‑Farber Associate Regulatory Coordinator. Additionally, 0-1 years of experience in a medical, scientific research, or technology‑oriented business environment is preferred, along with a basic understanding of clinical trial conduct.
Supervisory Responsibilities : None Patient Contact : None.
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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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 interacts with the Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the various DF/HCC institutions.
Remote position with occasional on‑site time in Boston, MA. The selected candidate must reside and work remotely in a New England State (MA, ME, NH, CT, RI, VT).
Responsibilities
Prepare and submit all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval.
Prepare and submit 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.
Prepare, maintain and organize regulatory files for each assigned study in compliance with study sponsor requirements; Industry sponsor, DF/HCC sponsored etc.
Maintain various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion.
Assist 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.
Establish and maintain 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.
Assist 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.
Knowledge, Skills, and Abilities
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.
Proficient in the use of computers, Microsoft applications and databases.
Experience with medical terminology.
Minimum Job Qualifications The position requires a bachelor’s degree or 1 year of experience as a Dana‑Farber Associate Regulatory Coordinator. Additionally, 0-1 years of experience in a medical, scientific research, or technology‑oriented business environment is preferred, along with a basic understanding of clinical trial conduct.
Supervisory Responsibilities : None Patient Contact : None.
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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