Dana-Farber Cancer Institute
Regulatory Coordinator - Breast Oncology
Dana-Farber Cancer Institute, Boston, Massachusetts, us, 02298
Regulatory Coordinator – Breast Oncology
2 days ago – Be among the first 25 applicants.
In this role, the Regulatory Coordinator (RC) works under the direction of the Breast Oncology Principal Investigator(s), Regulatory Operations Manager, Clinical Research Manager, and/or 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. The position collaborates with faculty, study team members, external institutions, cooperative groups, clinical trials experts, pharmaceutical industry representatives, federal agencies, and other research organizations. The RC interacts with the Office for Human Research Studies (OHRS), Office of Data Quality (ODQ), and Clinical Trials Offices at various DF/HCC institutions.
Remote Position
– This position is remote with occasional on‑site time in Boston, MA (as needed). The selected candidate must reside and work remotely in a New England State (MA, ME, NH, CT, RI, VT).
Regulatory Compliance
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 such as IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to agencies including the FDA and Office of Biotechnology Activities (OBA).
Maintain and organize regulatory files for each assigned study in compliance with sponsor requirements (Industry sponsor, DF/HCC sponsored, etc.).
Maintain various regulatory tracking databases related to study recruitment, subject enrollment, and study progress and completion.
Assist in 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 throughout the start‑up process, providing regular updates and ensuring all start‑up activities are completed.
Create and maintain tracking for all subsequent submissions to the SRC/IRB (protocol & consent amendments, safety reporting, deviation, violation, exception, or other event reporting). Ensure regulatory reporting requirements are met for the Study Sponsor, FDA, IRB, etc.
Key Stakeholder Interfacing
Establish and maintain regular communication with the study team, study sponsor, and applicable regulatory agencies/offices to ensure all required information is relayed and systematically documented.
Serve as facilitator for the study team and sponsor regarding study status, critical safety issues, upcoming protocol/consent and IDB amendments, and applicable protocol training.
Leadership and Professionalism
Maintain working knowledge of current regulations, regulatory guidance, and local policies.
Assist the Clinical Research Manager with regulatory‑based training and implementation of new or revised regulation, guidance, or local policy.
Present regulatory status for the disease group portfolio at applicable research meetings.
Bachelor’s degree required.
Experience working in a medical or scientific research setting or a comparable technology‑oriented business environment preferred.
Fundamental knowledge of the conduct of clinical trials is preferred.
Required Competencies
Perform day‑to‑day responsibilities as described above with regular and ongoing training and supervision.
Demonstrate fundamental knowledge and, where possible, proficiency in DFCI, DF/HCC, ICH/GCP, FDA policy/guidance/regulation; understanding of the IRB submission & approval process; regulatory binder maintenance; PI‑initiated/multi‑center trials; protocol and consent design; FDA IND and other regulatory submissions.
Knowledge, Skills, and Abilities Required
Excellent written and oral communication skills; maintain confidentiality, 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.
Proficiency in computers, Microsoft applications, and databases.
Experience with medical terminology.
Pay Transparency Statement The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and the candidate’s relevant experience, skills, and qualifications.
Hourly Range:
$26.70/hr – $29.66/hr
EEO Statement 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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In this role, the Regulatory Coordinator (RC) works under the direction of the Breast Oncology Principal Investigator(s), Regulatory Operations Manager, Clinical Research Manager, and/or 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. The position collaborates with faculty, study team members, external institutions, cooperative groups, clinical trials experts, pharmaceutical industry representatives, federal agencies, and other research organizations. The RC interacts with the Office for Human Research Studies (OHRS), Office of Data Quality (ODQ), and Clinical Trials Offices at various DF/HCC institutions.
Remote Position
– This position is remote with occasional on‑site time in Boston, MA (as needed). The selected candidate must reside and work remotely in a New England State (MA, ME, NH, CT, RI, VT).
Regulatory Compliance
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 such as IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to agencies including the FDA and Office of Biotechnology Activities (OBA).
Maintain and organize regulatory files for each assigned study in compliance with sponsor requirements (Industry sponsor, DF/HCC sponsored, etc.).
Maintain various regulatory tracking databases related to study recruitment, subject enrollment, and study progress and completion.
Assist in 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 throughout the start‑up process, providing regular updates and ensuring all start‑up activities are completed.
Create and maintain tracking for all subsequent submissions to the SRC/IRB (protocol & consent amendments, safety reporting, deviation, violation, exception, or other event reporting). Ensure regulatory reporting requirements are met for the Study Sponsor, FDA, IRB, etc.
Key Stakeholder Interfacing
Establish and maintain regular communication with the study team, study sponsor, and applicable regulatory agencies/offices to ensure all required information is relayed and systematically documented.
Serve as facilitator for the study team and sponsor regarding study status, critical safety issues, upcoming protocol/consent and IDB amendments, and applicable protocol training.
Leadership and Professionalism
Maintain working knowledge of current regulations, regulatory guidance, and local policies.
Assist the Clinical Research Manager with regulatory‑based training and implementation of new or revised regulation, guidance, or local policy.
Present regulatory status for the disease group portfolio at applicable research meetings.
Bachelor’s degree required.
Experience working in a medical or scientific research setting or a comparable technology‑oriented business environment preferred.
Fundamental knowledge of the conduct of clinical trials is preferred.
Required Competencies
Perform day‑to‑day responsibilities as described above with regular and ongoing training and supervision.
Demonstrate fundamental knowledge and, where possible, proficiency in DFCI, DF/HCC, ICH/GCP, FDA policy/guidance/regulation; understanding of the IRB submission & approval process; regulatory binder maintenance; PI‑initiated/multi‑center trials; protocol and consent design; FDA IND and other regulatory submissions.
Knowledge, Skills, and Abilities Required
Excellent written and oral communication skills; maintain confidentiality, 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.
Proficiency in computers, Microsoft applications, and databases.
Experience with medical terminology.
Pay Transparency Statement The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and the candidate’s relevant experience, skills, and qualifications.
Hourly Range:
$26.70/hr – $29.66/hr
EEO Statement 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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