Research Project Manager I - Pediatric Oncology Hematological Malignancy

US-MA-Boston
3 months ago
Job ID
2017-8360
Category
Clinical Research
Type
full time
Grade
22

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. This position is in the Pediatric Hematologic Malignancy Program within the Dana-Farber/Boston Children’s Cancer and Blood Disorders Center.  This RPM will be responsible for managing multiple clinical research protocols and Sponsor activities for PI Initiated Multi-Center protocols researching relapsed acute lymphoblastic leukemia and histiocytosis.  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. Specific tasks and responsibilities are varied and dependent upon project aims, scope and duration.

Responsibilities

The Research Project Manager I 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:

  1. Responsible for day-to-day oversight and management of assigned projects.
  2. Responsible for development and maintenance of Trial Master File (TMF).
  1. Assists PI with protocol and consent form development for initial application and with subsequent amendment changes.
  2. Initiates, plans, facilitates and oversees the research project start-up, active and close out phases; for PI Initiated / Multi Center.
  3. Responsible for Case Report Form design with PI directives. Maintain study-related databases, and prepare protocol-related reports as needed.
  4. May be responsible for scheduling research team meetings and conference calls, facilitating mailings and other project-related administrative tasks.

Qualifications

 

Bachelor's degree required in a field relevant to clinical research and 3 – 5 years experience with project management and experience working on clinical trials (multi-center, oncology trials perferred). Experience in an academic institution and proven history of success in clinical research field is preferred. Must have knowledge of regulatory affairs, research ethics and the responsible conduct of research.

 

 

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