• Research Project Manager - Clinical Trials

    Location US-MA-Boston
    Job Posted Date 3 weeks ago(10/23/2018 8:51 PM)
    Job ID
    2019-12906
    Category
    Clinical Research
    Type
    full time
    Grade
    23
  • 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 Research Project Manager (RPM) is responsible for assigned day-to-day coordination and overall management of sponsor activities for assigned clinical trials; primarily multi-center, PI-initiated trials. Sponsor activities include coordinating trial startup and site startup activities, providing training to participating site research staff, regulatory submissions, safety event tracking and reporting, deviation/violation tracking and reporting, participant accrual tracking and reporting, conducting teleconferences, vendor management, coordinating communication with regulatory authorities and manufacturers, etc. The RPM will be responsible to report on his or her defined deliverables, to identify variances in project plan and to develop contingency plans when necessary to keep project milestones on track. The RPM will have a dual report in to their disease group manager and PIs and to CTO Leadership to develop and implement strategies that will ensure compliance, consistency, and accountability in all assigned clinical research activities conducted at DFCI. Specific tasks and responsibilities are varied and dependent upon project aims, scope and duration.

     

    The Research Project Manager may also be responsible for the coordination of National Clinical Trial Network (NCTN) studies.  The RPM will also be responsible for coordination and management of main member and affiliate audits, sponsor or regulatory agency audits for the NCTN program. This may involve scheduling, booking rooms, managing the daily activities of the audit, coordinating the collection of regulatory documents, responding to auditor’s questions and responding to audit findings.

     

    The RPM may be assigned to support the NCTN sites outside of Dana-Farber as well as collaborate with the Grants Management team responsible for the Lead Academic Participating Sites (LAPS). This includes annual updates to the grant progress report, compiling information for the NCTN grant submission, answering financial questions related to studies and site inquiries.

     

    A Research Project Manager may also be assigned to oversee various operational and training aspects of the EPIC / OnCore application used by the DFCI Research Enterprise.  The RPM will work closely and collaboratively with a variety of faculty and staff at all levels throughout DFCI/BWH, and will work in collaboration with the OnCore IS team and other key stakeholders.  The RPM will develop infrastructure, procedures, and tracking systems for project management services performed.  Project management responsibilities would include coordinating the on boarding of new research staff training, maintaining workflows, facilitating all questions related to OnCore and defining grant and research specific reporting for the DFCI. The RPM will be supervised and supported by the CTO Leadership team to develop and implement strategies that will ensure compliance, consistency, and accountability in all assigned clinical research activities conducted within the system at DFCI. This individual is responsible for creating a proactive, knowledgeable and cohesive project management platform that will support the research community.

    Responsibilities

    The Research Project Manager will work independently under general supervision of a more senior manager within their disease group and or the Clinical Trials Office. This position may be responsible for some or all of the following:

    • Responsible for day-to-day oversight and management of assigned projects.
    • Responsible for development and maintenance of Trial Master File (TMF),
    • Assists PI with protocol and consent form development for initial application and with subsequent amendment changes.
    • Initiates, plans, facilitates and oversees the research project start-up, active and close out phases; for PI Initiated / Multi Center.
    • Responsible for Case Report Form design with PI directives. Maintain study-related databases, and prepare protocol-related reports as needed.
    • May be responsible for scheduling research team meetings and conference calls, facilitating mailings and other project-related administrative tasks.
    • Oversee the coordination, execution and overall management of several Phase I, II, III PI-Initiated / Multi-Center oncology trials.
    • Assist senior manager(s) in the development of a project plan that serves as a guiding document that provides overall direction, expectation of deliverables and stated milestones for the participating sites to ensure the success of the project.
    • Responsible for assuring that the project team meets all deadlines and is also to maintain an ongoing working relationship with Research team and Principal Investigators.
    • Responsible for developing the systems, tools, and infrastructure needed for project management core activities, including study start-up activities, coordinating and managing site activation, research staff training, regulatory submissions, event tracking and reporting, deviation and violation tracking and reporting, participant accrual tracking and reporting.
    • Prepares and presents status reports to key stakeholders. Depending on project needs, these reports may include information about project timelines, status of deliverables, and/or resources requirements

    Qualifications

    • Bachelor’s degree required in a field relevant to clinical research, and 5 plus years experience with project management and experience working on clinical trials (multi-center, oncology trials preferred).
    • Experience in an academic institution and proven history of success in clinical research field is preferred.
    • Must have strong knowledge of regulatory affairs, 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.

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