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Research Project Manager II - Clinical Trial Office

Company: Dana-Farber Cancer Institute
Location: Brookline
Posted on: June 6, 2021

Job Description:

Overview

The Research Project Manager II position will be responsible for overseeing a Dana-Farber Cancer Institute sample and data collection study. This study is designed to facilitate the identification, storage, and use of specimens during the course of clinical care and includes a component with return of genomic or sequencing results to patients.

Activities include coordinating trial startup and site startup activities, providing training to participating research staff, regulatory submissions, safety event tracking and reporting, deviation/violation tracking and reporting, participant accrual tracking and reporting, manage the data associated with the research projects including the creation of databases, 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 report in to the study PIs, Clinical Trials Office and the Office of Clinical Research to develop and implement strategies that will ensure compliance, consistency, and accountability in all assigned clinical research activities conducted at DFCI. Specific tasks,responsibilities and supervision of staff are varied and dependent upon project aims, scope and duration.

Responsibilities

The Research Project Manager II will work independently under general supervision of a more senior manager within 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). Perform daily study activities including patient registration and serve as the primary study contact for disease group staff. 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. Create and provide a training curriculum for various institutional staff. Maintain study-related database and prepare protocol-related reports as needed. Responsible for scheduling research team meetings and conference calls, facilitating mailings and other project-related administrative tasks. 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 teams 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 oncology clinical trials, biorepository / biobank studies or genomics projects. 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.

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.

Keywords: Dana-Farber Cancer Institute, Brookline , Research Project Manager II - Clinical Trial Office, Other , Brookline, Massachusetts

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