Clinical Research Project Manager

3 weeks ago

Boston, United States Dana-Farber Cancer Institute Full time

Waldenstrom's Macoglobulinemia Think Tank Network (WM-NET) is a think tank network for clinical and research programs dedicated to Waldenstrom's Macoglobulinemia. The vision of the WM-NET is to advance the search for treatment, cures, and prevention of disease by convening collaborative groups of practicing clinician-researchers to 1) identify important clinical questions, 2) design clinical trials to answer them and 3) put the results into practice more rapidly through large-scale engagement.

Additionally, the network will allow for faster accrual, and the ability to bring innovative phase II and III clinical trials closer to patients and facilitate the participation of underrepresented populations.

The WM-NET will consist of a group of 4 core members from academic centers with a proven track-record of excellence and high volume of patients with WM, with a goal to expand to 10+ affiliate centers. The CTO PI-Initiated Research Project Manager for WM-NET (CTO RPM) is responsible for assigned day-to-day coordination and overall management of WM-NET activities for assigned clinical trials and program; primarily multi-center, PI-initiated trials. 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 CTO 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. 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. Responsible for day-to-day oversight and management of assigned projects. 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 Bachelor's degree required in a field relevant to clinical research, and 5 plus 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 is preferred. Must have strong knowledge of regulatory affairs, research ethics and the responsible conduct of research. 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. EEOC Poster

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