• Assistant Clinical Research Manager - Breast Oncology Center

    Location US-MA-Boston
    Job Posted Date 1 month ago(9/11/2019 3:06 PM)
    Job ID
    2019-15933
    Category
    Clinical Research
    Type
    full time
    Grade
    21
  • 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 Breast Oncology Center (BOC) is recruiting a Assistant Clinical Research Manager (ACRM) to work within the clinical research program and assist in the management of the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator.  These positions, in collaboration with the program’s Clinical research Managers, physicians, and research nursing staff, are responsible for assisting with the design, implementation and evaluation of their program’s clinical research activities, related regulatory oversight, and will provide day to day supervision of their program’s clinical research staff as needed.   

     

    This position is designed to be a transition role. It is intended for new managers with no prior supervisory experience.

    Responsibilities

    Clinical Trials Operations

    • Assistant Clinical Research Managers (ACRM) will be responsible for assisting the Clinical Research Manager with the oversight of their disease group’s clinical trial portfolio and all related regulatory and compliance requirements.
    • The ACRM will assist the CRM will all aspects of study start up, active and close out activities for the group’s portfolio. They will be responsible for the required tracking of all protocol development, submission, review and approval milestones.
    • The ACRM will assist with the oversight of subject enrollment, protocol treatment and follow-up care processes for protocol patients.
    • Assist with the oversight of registration of protocol patients, study group registrar and pharmaceutical company as outlined in protocol.

    Regulatory & Compliance

    • Assists in the responsibility for essential document compliance for entire portfolio. Implements systems to monitor and ensure regulatory document collection and maintenance compliance. 
    • Assists in the responsibilities for all clinical trial reporting requirements; safety event, annual approval, deviations etc. May implement systems to monitor portfolio compliance.
    • Assists the study team to be maintain an “audit ready” research environment

    Data Management & Clinical Trial Monitoring

    • Assists CRM with responsibility for data management and compliance for entire portfolio. Maintains schedules and procedures necessary for timely and complete data collection.
    • Regularly reports data compliance status to key stakeholders; i.e. DFCI PI, study Sponsor, DFCI CTO. Helps to implement corrective action to maintain data compliance when necessary.
    • Submits required “progress / tracking “reports to key stakeholders, when applicable.

    Staff Training & Development

    • Will assist the CRM with the recruitment and oversight of coordinator staff as well as ensures that staff have completed mandatory training in a timely manner. Will help implement program specific on-boarding and orientation process and may participate in annual performance evaluations and competency assessments of research staff as needed.

    Qualifications

    • Bachelor's Degree required.
    • Minimum of 3-5 years of related experience preferred.
    • Experience in protocol development, data compilation and analysis.
    • Must be able to perform day to day responsibilities independently with minimal supervision from manager. 
    • Has the ability to identify regulatory scenarios that require consultation. Has a good understanding of clinical trials start-up, active and close out phases. 
    • Has a good understanding of clinical research local policy and federal regulation. 



    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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