Regulatory Affairs Specialist - Clinical Trial Office
Company: Dana-Farber Cancer Institute (DFCI)
Posted on: January 4, 2022
Regulatory Affairs Specialist - Clinical Trial Office
Job DetailsJob ID:
10 Brookline Place West, Brookline, MA 02445
Full Remote: 4-5 days remote/wk OverviewThe Regulatory Affairs
Specialist (RAS) is responsible for providing strategic, tactical
and operational direction and support to investigators and study
teams for working within regulations to expedite the development
and delivery of safe and effective healthcare products to DFCI
patients and the world. The RAS will work closely and
collaboratively with a variety of individuals at all levels
throughout DFCI, including faculty, investigators and staff, and
also with representatives from the pharmaceutical, biotechnology,
and medical device industries, federal and international regulatory
agencies, and other research organizations. The RAS will work
interactively with the Dana-Farber/Harvard Cancer Center (DF/HCC)
Office for Human Research Studies (OHRS) and Office of Data Quality
(ODQ), as well as clinical trials offices at other DF/HCC
institutions. The RAS will be supervised and supported by senior
CTO management and will support the mission and goals of the DFCI
clinical research program. Specific tasks and responsibilities are
varied and dependent upon different types of work that are done
across the various functions that comprise the regulatory
life-cycle at DFCI.This position is 4-5 days remote. Only
applicants living in Massachusetts, Rhode Island, or New Hampshire
at the time of employment will be considered.RequirementsRegulatory
- Keeps abreast of relevant regulatory procedures and changes in
the federal and local regulatory climate.
- Responsible for facilitating, overseeing and managing
regulatory inquiries regarding protocol development, human subject
protections, Good Clinical Practice (GCP) guidelines, and DFCI and
- Serves as a centralized regulatory resource for
Sponsor-Investigators and their study teams to ensure internal and
external processes are established and functioning.
- Provides regulatory input pertinent to the creation, internal
review and validation, and submission of investigator-sponsored
regulatory filings to the FDA (primarily Investigational New Drug
(IND) and Investigational Device Exemption (IDE) applications).
Activities include but are not limited to advice and oversight
regarding IND/IDE determination; guidance and assistance with
preparation of IND/IDE applications; coordination and oversight of
IND/IDE submissions; and compliance with local, federal and
international requirements for periodic amendments and
- Monitors, utilizes and maintains CTO tracking and control
systems to manage regulatory-associated processes, including but
not limited to e-Regulatory Management and the IND and IDE
databases. Clinical Trials Operations
- Problem-solves with or advises investigators and study teams on
regulatory aspects that could impact the planning and development
of research protocols and other protocol documents in order to
ensure timely scientific/IRB review and approval.
- Evaluates research protocols for administrative completeness,
compliance with DF/HCC administrative policies and procedures and
applicable regulatory requirements, and operational components
specific to domestic and international multicenter trials in order
to facilitate timely review and approval of trials and the safe,
effective, and efficient conduct of trials at DFCI.
- Assesses the acceptability of regulatory documentation to
comply with regulatory requirements for clinical trials.
- Contributes to the development, review and maintenance of
standard operating procedures and working instructions related to
the conduct of clinical trials at DFCI.
- May be assigned to oversee various operational aspects of the
EPIC and OnCore applications used by the DFCI research enterprise,
including but not limited to activation procedures, report
development and generation, and identification of system
- Provides information on regulatory requirements to assigned
disease program partners.
- Interacts with other clinical trials offices, departments and
regulatory inspection teams, as required.
- Contributes to the CTO regulatory and clinical research
educational and training curriculum by assisting with the delivery
of training for general research personnel or being responsible for
training of regulatory staff on current and new regulatory
- Provides guidance to investigators and study teams regarding
completion of IRB regulatory submissions (e.g., new project
applications, activation, amendments, and continuing reviews) and
recommendations on how best to address specific issues and concerns
identified through the scientific review and IRB review processes.
Leadership and Professionalism
- Participates in the development and implementation of DFCI
- Contributes to the development and functioning of the
Regulatory Affairs program by identifying issues changes and
developing innovative ways to view and resolve the issue.
- Participates in professional associations and serves on
institutional and department/division committees and task forces.
- Bachelor's Degree in life sciences or other health related
discipline required, with a minimum of 5 years of related
experience, or 3-5 years of related experience with a Master's
- Must possess excellent attention to detail and follow through,
organizational, communication and interpersonal skills. Position
requires the capacity to comprehend complex structures and
- Must have the ability to exercise good judgment in ambiguous
situations and have a proven history of adaptability within a
rapidly changing environment.
- Requires the ability and initiative to prioritize and handle a
variety of tasks and assignments simultaneously.
- Strong analytic and problem solving skills and the ability to
effectively manage a large workload independently with minimal
supervision are required.
- Computer skills include the use of Microsoft Office
applications and databases. Working knowledge of Livelink, EPIC and
OnCore applications is desirable. Familiarity with medical
terminology is required. Located in Boston and the surrounding
communities, Dana-Farber Cancer Institute brings together world
renowned clinicians, innovative researchers and dedicated
professionals, allies in the common mission of conquering cancer,
HIV/AIDS and related diseases. Combining extremely talented people
with the best technologies in a genuinely positive environment, we
provide compassionate and comprehensive care to patients of all
ages; we conduct research that advances treatment; we educate
tomorrow's physician/researchers; we reach out to underserved
members of our community; and we work with amazing partners,
including other Harvard Medical School-affiliated hospitals.
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 groups as
protected by law.
Keywords: Dana-Farber Cancer Institute (DFCI), Brookline , Regulatory Affairs Specialist - Clinical Trial Office, Other , Brookline, Massachusetts
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