Clinical Research Coordinator - Pediatric Oncology Hematologic Malignancy
Company: Dana-Farber Cancer Institute (DFCI)
Posted on: January 5, 2022
Clinical Research Coordinator - Pediatric Oncology Hematologic
Job DetailsJob ID:
10 Brookline Place West, Brookline, MA 02445
Onsite:Up to 1 day remote/wk OverviewThe Clinical Research
Coordinator work within the clinical research program and support
the research team in the overall conduct of clinical trials using
Good Clinical Practice under the auspices of the Principal
Investigator(s) and the DFCI Clinical Trials Office. The CRC will
be responsible for the primary data collection and management of
patient clinical information as it pertains to participation in
clinical trials. Ensures timely collection of protocol related
samples including shipment to outside entities as required.
Maintains regulatory binders and ensures study compliance with all
state, federal, and IRB requirements. May be responsible for IRB
protocol submissions (amendments, continuing reviews, and minimal
risk protocols). This individual may also screen patients for
protocol eligibility, obtain informed consent, and register study
participants to clinical trials. Some travel may be
- Oversight of the clinical trials start-up process from receipt
of protocols through the Scientific Review Committee and IRB
submissions, and site activation activities.
- Responsible for data reporting and management, collection of
source documents, use and development of case report forms, adverse
events reporting, filing and archiving of study records, and
resolution of data queries.
- Prepare and or complete regulatory related reports and IRB
submissions. Maintain and organize study regulatory binders, enter
all required study data on an ongoing basis.
- Ensure all study related samples are collected, properly
prepared and shipped according to the protocol requirements and
- Responsible for organizing and preparing for both internal and
external auditing and study monitoring visits.
- Coordination and management of clinical trials, including
communication with Sponsors and regulatory authorities.
- Close-out of clinical trials, including contributing to
research articles, audit preparation, and communication with
regulatory agencies and other disciplines involved.
- Interact with study participants as directed/required by the
protocol and/or study team.
- May be responsible for tissue sample work. Qualifications
- Bachelor's Degree required, with 0-1 years of related
experience preferred. Experience working in a medical or scientific
research setting or comparable technology orientated business
- Excellent organization and communications skills required.
Strong interpersonal skills; ability to effectively interact with
all levels of staff and externals contacts. Must be detail oriented
and have the ability to follow-through. Ability to effectively
manage time and prioritize workload. Must practice discretion and
adhere to hospital confidentiality guidelines at all times. Must
have computer skills including the use of Microsoft Office. 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 , Clinical Research Coordinator - Pediatric Oncology Hematologic Malignancy, Other , Brookline, Massachusetts
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