Research Project Manager II - Janeway Lab

Job Details

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Job ID:
23355

Location:
450 Brookline Ave, Boston, MA 02215

Category:
Clinical Research

Employment Type:
Full time

Overview

We are seeking a talented, motivated, and collaborative Research Project Manager to support a state-of-the-art dry lab utilizing genomic and transcriptomic sequencing to elucidate the underlying drivers of advanced pediatric cancers and sarcomas, to guide targeted therapy recommendations for individual patients and to further develop precision medicine for children with cancer.  The position is based in the Janeway Lab at Dana-Farber Cancer Institute with collaborations at Boston Children’s Hospital, Brigham and Women’s Hospital, the Broad Institute, and pediatric oncology centers across the U.S. The research project manager will work with other members of the laboratory and with the Pediatric Oncology Clinical Translation Investigation Program staff with a focus on project management and supervising research assistants in conduct of sample-based genomics investigation and medical record clinical data abstraction.

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.

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 also 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 Director of Operations 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.

Requirements

This position may be responsible for some or all of the following:

  • Responsible for day-to-day oversight and management aspects of assigned projects according to protocol specifications. 
  • Confirm patient eligibility and consent, including reviewing data in the patient medical records. May be responsible for overseeing recruitment, consenting and enrollment of study participants.
  • Responsible for database management which may include database design with PI directives, informatics and data dictionaries. Maintain study-related databases, and prepare protocol-related reports. 
  • Responsible for overseeing IRB submissions, correspondence, and regulatory binders, including minor administrative amendments.
  • Maintain HIPAA confidentiality and data integrity of patient information, which may include medical and/or genetic testing information. 
  • Oversee specimen collection.
  • Facilitate project start-up for multi-sites studies.
  • May be responsible for scheduling research team meetings and conference calls, facilitating mailings and other project-related administrative tasks. 
  • Will oversee workflow direction and conduct of approximately 3 junior level staff
  • 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.

In addition to performing the above responsibilities, this position will require the individual to work on an increasingly independent basis with less supervision, and may also be required to:                                            

  • 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

  • Bachelors' degree in health or sciences related field required with 5 years of experience in a related field such as management of translational laboratory, clinical molecular laboratory, biobanking or large scale molecular characterization protocols.
  • Master's degree preferred. 
  • Essential attention to detail, organizational, communication, and interpersonal skills. 
  • Excellent ability to work independently and balance multiple projects and tasks simultaneously.
  • Knowledge of regulatory affairs for sample-based and / or medical record review research.
  • Strong ability to both work as a member of and effectively and proactively lead teams.
  • Experience with database management (REDCap preferred).
  • Comfortable in a clinic environment, including ability to interact with patients.
  • Prior experience or interest in pediatric oncology is desired.


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.

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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