Regulatory Coordinator - Lymphoma Clinical Trials
Company: Dana-Farber Cancer Institute
Posted on: June 6, 2021
The Regulatory Coordinator (RC) works under the direction of the
Principal Investigator(s), Clinical Research Manager 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. Works interactively with the
Office for Human Research Studies (OHRS), Quality Assurance of
Clinical Trials (QACT), and the Clinical Trials Offices at the
various DF/HCC institutions.
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.
- 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
- 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 QACT, Industry Sponsors, and third party
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 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
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
- Bachelor's degree (BA, BS) in life sciences, nursing, or other
related discipline is required.
- 0-1 years of related research experience or research specific
training. Fundamental knowledge of the conduct of clinical trials
- Must possess excellent written and oral communication skills,
maintain confidentiality of information, demonstrate good
decision-making and judgment and have attention to detail and
- 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.
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, Brookline , Regulatory Coordinator - Lymphoma Clinical Trials, Other , Brookline, Massachusetts
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