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,Â 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.Â 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.Â The RPM will develop infrastructure, procedures, and tracking systems for project management services performed.Â 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.
The role of the individual in this position will be to provide organizational, research and data management support for the expansion of the Cancer Care Equity Programâ€™s Clinical Access initiative at the DFCI Longwood campus to additional Federally-Qualified Health Centers (FQHCs) in the Boston area (Dimock Health Center and Harvard Street Neighborhood Health Center).
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 I will work independently under general supervision of a more senior manager within their disease group or Clinical Trials Office. Â Â 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),
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.
Ability to perform routine tasks related to the coordination of assigned clinical trials.
Ability to identify problems or potential obstacles and escalate appropriately.
Working understanding of DF/HCC SOPs and applicable federal and local regulations/policies.
Independently performs all primary duties listed above under general supervision.Has critical thinking skills and an appropriate level of good professional judgment
MINIMUM JOB QUALIFICATIONS:
Bachelor's degree required in a field relevant to clinical research and 1-3 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.
Preferred Qualifications Include:
Significant experience in applied research settings, with focus on outcomes and/or academic research;
Excellent data management skills;
REDCap experience preferred
Strong data analysis skills
Outstanding coordination, communication, interpersonal and organizational skills;
Ability to work independently and balance multiple projects simultaneously;
Discretion and solid judgment in handling extremely sensitive patient information;
Motivated to work in an academic clinical team environment;
Masterâ€™s degree preferred.
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.
Internal Number: 2021-21655
About Dana-Farber Cancer Institute
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 under-served members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.