The Research Project Manager (RPM) is responsible for assigned day-to-day coordination and overall management of sponsor activities for assigned clinical trials Sponsor activities include coordinating trial startup and site startup activities, safety event tracking and reporting, deviation/violation tracking and reporting, participant accrual tracking and reporting, and/or conducting teleconferences. 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 develop and implement strategies that will ensure compliance, consistency, and accountability in all assigned clinical research activities conducted in the DFCI network. 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 other key stakeholders. The RPM will develop infrastructure, procedures, maintaining workflows, and tracking systems for project management services performed. The RPM will be supervised and supported by the CORP Leadership to develop and implement strategies that will ensure compliance, consistency, and accountability in all assigned clinical research activities conducted within the network at DFCI. This individual is responsible for creating a proactive, knowledgeable, and cohesive project management platform that will support the research community.
This role requires 2-3 days per week of local travel to our various MA/NH regional Dana-Farber locations (Longwood Medical Area, Chestnut Hill, Brighton, Foxborough, Milford, South Shore, Merrimack, Londonderry NH). The selected candidate may only reside & work remotely within the New England states (ME, VT, NH, MA, CT, RI).
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
ResponsibilitiesThe Research Project Manager will work independently under general supervision of a more senior manager within their disease group or 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).Initiates, plans, facilitates and oversees the research project start-up, active and close out phases. 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 clinical 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.Participation in study and research meetings for each regional site as scheduled. 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 requirementsRegional site data collection, maintaining metrics, and circulating dashboards and reports to regional site leadership and staff and the Clinical Trials Office. Assist in implementation of OnCore financial module and ensuring seamless process across all regional sites.Travels to DFCI regional sites on a regular basis to meet with stakeholders in person. Qualifications Bachelor’s degree required in a field relevant to clinical research. Minimum of 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 strong knowledge of regulatory affairs, research ethics and the responsible conduct of research.REQUIRED COMPETENCIES:
Ability to perform routine tasks related to the coordination of assigned clinical trials without supervision.Ability to identify problems or potential obstacles and resolve many situations independently.Demonstrates an ability to mentor others and assist in the resolution of complex issues.Exhibits good judgment when determining appropriate escalation.Thorough and complete understanding of applicable federal and local regulations, DF/HCC policies and standard operating procedures, and DFCI monitoring practices.Independently performs all primary duties listed above with minimal supervision.At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.
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 characteristics protected by law.
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