Dana-Farber Cancer Institute

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Clinical Trials Monitor I - Breast Oncology Center

Clinical Trials Monitor I - Breast Oncology Center

Job ID 
2018-8517
Location 
US-MA-Boston
Category 
Clinical Research
Type 
full time
Grade 
21
Job Posted Date 
10/5/2017

More information about this job

Overview

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 Division of Women's Cancers Breast Oncology Center (BOC) is currently recruiting a Clinical Trial Monitor (CTM).  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 and Disease Center Research Manager, 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. Monitoring will be performed 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.

 

This position requires some travel (~20%) and the rest of the time the CTM would be working from our Boston office location in the Longwood Medical Area.

Responsibilities

  • 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.

Qualifications

 MINIMUM JOB QUALIFICATIONS:

  • 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.

     

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

Extensive knowledge of federal, state and local regulations concerning relevant research compliance areas. Experience in the interpretation of legislation, regulations, policies, procedures, and ethical principles in research compliance are required. The ability to translate regulations into operational policies and procedures is essential. Knowledge of the broader research environment, including emerging regulatory trends, best practices at other institutions, conflict of interest, responsible conduct of research, and other issues is highly desirable. Excellent communication skills and an ability to work with diverse constituencies within an academic community. Capacity to handle multiple activities simultaneously and to effectively prioritize tasks and responsibilities. Must be team oriented, results driven and able to motivate others. Must be computer literate in Microsoft Office suites, including Word, Excel and PowerPoint, and be able to travel depending on project needs.

 

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.

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