Regulatory Coordinator - Breast Oncology

Dana-Farber Cancer Institute, Inc.; Boston (MA); Remote; USD 56,000 - 62,000; Full time

Job summary

Dana-Farber Cancer Institute seeks a Regulatory Coordinator to manage regulatory submissions, maintain trial documents, and ensure compliance with DF/HCC policies, FDA, and ICH/GCP guidelines. The role collaborates with investigators, sponsors, OHRS, ODQ, and trial teams.

Work location is fully remote with occasional on-campus time in Boston; remote work allowed from New England states. The team supports breast oncology studies and collaborates across DF/HCC institutions.

Qualifications

• Bachelor’s degree or 1 year of experience as a Dana-Farber Associate Regulatory Coordinator.
• 0–1 years of experience in a medical, scientific research, or technology-oriented business environment preferred, with basic understanding of clinical trial conduct.
• Excellent written and oral communication, confidentiality, attention to detail and strong organization.
• Proficient in computers and databases; experience with medical terminology.

Responsibilities

• Prepares and submits protocol applications, amendments, continuing reviews, and informed consent for SRC/IRB review.
• Prepares regulatory documentation including IND/IDE, FDA reports, and SAEs to FDA and other agencies.
• Maintains regulatory files per sponsor requirements for various study types.
• Maintains regulatory tracking databases for recruitment, enrollment, and study progress.
• Assists in coordinating study monitoring visits with investigators, sponsors, and auditors.
• Tracks start-up packets and monitors progress to meet benchmarks.
• Communicates with stakeholders to ensure start-up activities are completed.
• Creates and maintains tracking for SRC/IRB submissions, safety reporting, deviations, and events.
• Maintains regular communication with study teams, sponsors, and regulatory offices for information flow.
• Serves as facilitator for study status, safety issues, and regulatory training; documents accordingly.
• Keeps up-to-date with current regulations and local policies; supports regulatory training.

Skills

Regulatory knowledge

Documentation management

Communication skills

Microsoft Office

Medical terminology

Education

Bachelor's degree

1 year Dana-Farber Associate Regulatory Coordinator experience

Tools

Regulatory databases

Job description

The Regulatory Coordinators (RC) works under the direction of the Principal Investigator(s), Regulatory Operations Manager, Clinical Research Manager and / or directly for the Clinical Trials Office to complete the regulatory requirements of the Breast Oncology 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.

This position's work location is fully remote with occasional time on-campus in Boston. The selected candidate may only work remotely from a New England state (ME, VT, NH, MA, CT, RI).

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.

• 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 requirement; 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 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.
• Establishing and maintaining 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
• 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

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

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.

EEO Poster

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 based on the candidate’s relevant experience, skills and qualifications.

For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA).

$55,530.00 - $61,700.00