Clinical Trials Monitor I - Breast Oncology
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POST DATE 9/1/2016
END DATE 2/17/2017
Dana-Farber Cancer Institute
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.
The Clinical Trials Monitor helps to ensure compliance of the clinical research enterprise with all related regulatory policies and guidelines, including federal, state, local, as well as the policies and procedures outlined by the Dana-Farber Cancer Institute and Dana-Farber Harvard Cancer Center (DF/HCC) consortium. Under the direction of Clinical Trials Office Leadership, s/he will assist in the design, development, implementation, and conduct of an effective monitoring program in accordance with Good Clinical Practice, institutional policies and procedures, and research protocols. The Clinical Trials Monitor will ensure that, for those clinical trials assigned for monitoring, the appropriate and required monitoring tasks and related activities occur as outlined in the monitoring plan and in compliance with all related regulatory standards. The Clinical Trial Monitor will be based on-site in Boston at Dana-Farber and will conduct monitoring through a combination of remote data review and onsite monitoring visits; therefore, a willingness and ability to travel occasionally is required. The Clinical Trials Monitor is responsible for multiple projects at a time, and must have strong time management skills in addition to working both independently and in a team environment. S/he will be responsible for promoting a culture of monitoring compliance and regulatory awareness within DFCI and DF/HCC.
* Ensure the Sponsor-Investigator and study team adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies and standard operating procedures, including DFCI CTO Monitoring standards and guidelines.
* Adhere to the protocols Data Safety Monitoring Plans; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms and other monitoring related tools and templates.
* Monitor clinical trial progress through a combination of remote data review and on site monitoring visits. Some travel will be required.
* Verify that trial data entered on the Case Report Form is consistent with patient clinical notes and other source documentation (source data verification).
* Independently coordinate upcoming and ongoing monitoring assignments while meeting expected timelines for completion of monitoring activities and submission of written monitoring reports.
* Assist in the development and writing of clinical trial monitoring plans.
* Provide recommendations and guidance to study specific monitoring teams and assist in audit readiness and preparation.
* Participate in regular monitoring team group meetings.
* Bachelor's degree in a field relevant to research compliance and 3+ years of progressively responsible clinical trials experience with 1+ years of monitoring experience. Experience in an academic institution is preferred, especially working in collaborative efforts with upper administrators, faculty and research staff as well as research support personnel. Must have expertise in research ethics and the responsible conduct of research.
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.