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Translational Research Project Manager II - Breast Oncology Center

Company: Dana-Farber Cancer Institute
Location: Boston
Posted on: August 21, 2019

Job Description:


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 Translational Research Project Manager (TRPM) is responsible for the assigned day-to-day coordination and overall management of assigned translational projects associated with Breast Oncology Investigator-Initiated investigational drug clinical trials and related secondary use protocols. The TRPM will be responsible for working with the Principal Investigator (PI) and disease program manager to establish systems to track, organize, and ship biospecimens such as blood (or byproducts of), tissue (fresh, frozen, archival), stool samples, or other fluids to internal or external laboratories being used for analysis of these specimens. Biospecimens will be shipped according to IATA/DOT regulations.

The TRPM will be responsible for ensuring that all legal agreements (MTA, LSA, DUA, CTA) are in place prior to transfer of any specimens or clinical data to parties external to Dana-Farber. The TRPM will be responsible to report on his or her defined deliverables, identify any issues in project plan and to develop contingency plans when necessary to keep projects on track.

The TRPM will work together with assigned Research Data Specialist (RDS) and other staff as needed to carry out the functions of their job. Specific tasks and responsibilities are varied and dependent upon project aims, scope and duration.


Primary Duties and Responsibilities

The Translational Research Project Manager will work independently under general supervision of a more senior manager within the Breast Oncology Center. This position may be responsible for some or all the following:

* Responsible for day-to-day oversight and management of assigned translational projects.

* Responsible for ensuring all regulatory paperwork and legal and/or data agreements are in place prior to transfer or biospecimens.

* Initiates, plans, facilitates and oversees translational research projects from start-up through initiation and closeout for all assigned PI-Initiated and Multicenter trials.

* Liaise with internal and external departments, laboratories, and companies to coordinate biospecimen and data shipments within project scope and timelines.

* Responsible for Case Report Form design with PI directives, as needed. Maintain study-related databases, trackers, 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.

Staff Hiring, Supervision, Training & Development

* Responsible for the recruitment and oversight of Research Data Specialists working on biospecimen projects. Ensure that all staff complete required mandatory and ongoing training in a timely manner. Develops and oversees a program specific on-boarding and orientation process and conducts annual performance evaluations and competency assessments for research staff.

* Develops a standard supervision schedule with research staff including periodic individual and group supervision meetings.

* Will communicate all personnel concerns to their immediate supervisor and to DFCI HR for the appropriate response and follow-up.


Minimum Job Qualifications:

* Bachelor's degree required in a field relevant to clinical research or laboratory studies

* 5+ 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 and/or experience working within a laboratory environment is preferred.

* Must have some 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.

Keywords: Dana-Farber Cancer Institute, Boston , Translational Research Project Manager II - Breast Oncology Center, Executive , Boston, Massachusetts

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