Site: The General Hospital Corporation
Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. The McCance Center for Brain Health in the Neurology Department at Massachusetts General Hospital (MGH) is an interdisciplinary research center with the mission to promote healthy brain aging and prevent neurodegenerative disease through innovative research. We focus on clinical trials for Alzheimer's Disease therapies including natural, drug, and lifestyle interventions. We are in an exciting phase of growth that includes launching a single site trial of a natural product combination and planning a platform trial to accelerate testing of multiple potential therapies for AD early intervention. The Clinical Research Project Manager II ("PM II") will work closely with Center leadership, site teams, and collaborators across Mass General Brigham as well as externally to develop, execute, and coordinate clinical studies. The PM II will utilize a broad range of project management tools to guide internal teams and assure that all deliverables are completed on time, within scope, and are of high quality. The PM II will provide oversight and leadership throughout the project life cycle from proposal through startup, implementation, and close out and will work closely with Principal Investigators, co-investigators, site personnel, cores, and vendors on clinical trial operations. Responsible for operational management of clinical trials including planning functional infrastructure and assessing compliance with study protocol, contracts, and policies. The candidate will plan, schedule, and facilitate meetings. The candidate must demonstrate superior organizational, time management, interpersonal, and communication (written and verbal) skills, as well as intellectual independence and initiative. The PM II must exhibit strong attention to detail, critically synthesize issues and prepare necessary materials to communicate to internal and external audiences. The PM II will contribute to the development of documents such as study protocols, informed consents, case report forms, monitoring plans, study reports, budgets, scopes of work, timelines, project plans, study progress metrics, and electronic data capture (EDC) systems and will submit documentation to the IRB, FDA, and Clinicaltrials.gov. The PM II will protect confidential and sensitive research data with integrity, ensure compliance with Good Clinical Practice (GCP), applicable FDA regulations, and Standard Operating Procedures (SOPs). The PM II will have experience in clinical trial phases of operation, including start-up, maintenance and close out phases; be detail oriented and able to manage several projects simultaneously; forge cross-functional working relationships; proactively identify issues and hurdles that may handicap the effective implementation of any given trial and resolve the issues efficiently. The ability to work both independently and as part of a team is essential to this job. This is a full-time (40 hours/week) position based out of our Assembly Row location in Somerville, MA, with occasional travel to Charlestown Navy Yard and other Mass General Brigham (MGB) sites. Job SummaryDescription Summary: Under the supervision and/or direction of the Registered Nurse, the Nurse Extern I performs various direct patient care activities in accordance with the Nursing Department policies and procedures. The Nurse Extern I is able to assist with the...
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