Clinical Trials Monitor - Transplant Clinical Trials
Company: Dana-Farber Cancer Institute
Location: Boston
Posted on: January 15, 2021
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Job Description:
The Clinical Research Specialist performs, coordinates, and
monitors all aspects of the regulatory process within clinical
trials in accordance with Good Clinical Practice, institutional
policies and procedures, and research protocols. Conducts site
visits to determine protocol and regulatory compliance, and
prepares required documentation. Responsible for multiple projects
and must work both independently and in a team environment. May
participate in protocol and study development and start up
processes including reviewing protocols, designing and/or reviewing
Case Report Forms, preparing informed consent documents, developing
study specific source document worksheets, and working with study
team management on operational strategies.* Assist in the
development and writing of clinical trial protocols.* Liaise with
investigators and disease groups on conducting clinical trials.*
Prepare and manage regulatory applications to federal and local
agencies (FDA, OHRS, etc.) and the related approval process.*
Locate and/or assess the suitability of study sites to conduct
clinical trials.* Monitor trial progress throughout its duration
which may include visiting study sites on a regular basis.* Verify
that data entered on the Case Report Form is consistent with
patient clinical notes and other source documentation (source data
verification).* Act as a regulatory resource for study sites by
maintaining regular contact with investigators and study teams
during the course of studies to ensure that compliance is
maintained.* Prepare reports as required regarding the status of
ongoing studies and make necessary recommendations for contingency
planning.* BS/BA degree required; Master's preferred. * Minimum of
5 years clinical research experience with oncology background
preferred.* Requires excellent verbal and written communication
skills with an in-depth knowledge of GCP guidelines, medical
terminology, and the clinical trial process. * In addition,
excellent interpersonal skills with strong organizational skills
and an attention to detail are needed. * Must be computer literate
and be able to travel depending on project needs.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, Boston , Clinical Trials Monitor - Transplant Clinical Trials, Other , Boston, Massachusetts
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