Clinical Research Coordinator - Pediatric Neuro-Oncology
Company: Dana-Farber Cancer Institute
Posted on: June 6, 2021
The 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 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.
- 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.
- 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.
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 , Clinical Research Coordinator - Pediatric Neuro-Oncology, Other , Brookline, Massachusetts
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