Regulatory Coordinator II

Dana-Farber Cancer Institute; Brookline (MA); On-site; USD 55,000 - 90,000; Full time

Job summary

A forward-thinking organization is seeking a Regulatory Coordinator to support innovative clinical trials in cancer research. This hybrid role combines regulatory compliance with clinical trial management, requiring excellent communication and organizational skills. The selected candidate will play a vital part in ensuring regulatory adherence and facilitating collaboration among key stakeholders. With a commitment to groundbreaking research and patient care, this position offers an exciting opportunity to contribute to lifesaving advancements in medicine while working within a diverse and inclusive environment.

Benefits

Health Insurance

Flexible Work Hours

Professional Development Opportunities

Retirement Savings Plan

Paid Time Off

Qualifications

• Experience with regulatory submissions and compliance.
• Strong organizational skills and attention to detail.

Responsibilities

• Prepare and submit regulatory documentation for clinical trials.
• Manage communication with study sponsors and regulatory agencies.
• Track and manage clinical trial start-up processes.

Skills

Regulatory Compliance

Clinical Trial Management

Communication Skills

Organizational Skills

Education

Bachelor's Degree in Life Sciences

Certification in Clinical Research

Tools

Regulatory Tracking Databases

Clinical Trial Management Software

Job description

Job Ref:43995
Location:10 Brookline Place West,Brookline,MA 02445
Category:Clinical Research
Employment Type:Full time
Work Location:Hybrid: 2-3 days onsite/week

Overview

The Clinical Trials Office and the Center for RAS Therapeutics is looking for a Regulatory Coordinator (RC) to provide regulatory support for this new initiative. The RC will work under the direction of the Principal Investigator(s), and will directly report into the Clinical Trials Office to complete the regulatory requirements for the specific RAS portfolio of trials across conducted across several disease groups. 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 help to develop a regulatory infrastructure and DFCI RAS Clinical Trial Dashboard to allow for better regulatory and operational oversight. 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 role is a hybrid position requiring 2-3 days onsite per week. The selected candidate may only reside & work remotely within the New England states (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.

Responsibilities

• Regulatory Compliance
  • Prepares and submits RAS Center protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval.
  • Prepares and submits RAS Center 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 RAS Center 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.
• Clinical Trial Management
  • Track and manage assigned new RAS Center 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.
• Key Stakeholder Interfacing
  • 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 with regard to 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
  • 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

SUPERVISORY RESPONSIBILITIES:

No direct supervisory responsibility may have a role in training new regulatory coordinators