Clin Trial Asst Proj Manager

The Massachusetts General Hospital Stroke and Neurocritical Care Research Center is one of the largest and most prolific stroke research centers in the country employing a diverse team of clinical researchers managing novel clinical trials in stroke and vascular diseases. The Center's staffing structure and project portfolio support professional growth of clinical research staff at all levels as well as successful facilitation of highly complex interventional trials and large-scale genetic, longitudinal, and observational studies. 

Our team is seeking a highly motivated individual to be part of a dynamic project management team responsible for the execution of a high-profile, multi-center clinical research study dedicated to validating promising predictive, diagnostic, target engagement and progression biomarkers of the brain small-vessel diseases involved in the vascular contribution to cognitive impairment and dementia (VCID). Reporting to a Project Manager, the Assistant Project Manager will assist the Project Managers and study team with the day-to-day management of this large-scale NIH-sponsored study and the successful execution of study-related activities across participating centers. The Incumbent will assist the Project Managers in effectively managing scope, schedules/timelines, budget, documentation, resources and quality of the study. The Assistant Project Manager will also assist with study management, including clinical site and vendor management, and study meeting planning and execution. For more information about one of the studies this role would work on, please visit the MarkVCID website: https://markvcid.partners.org/.

The Assistant PM will assist study Project Managers and staff with the following:

• Ensuring targets are met for patient recruitment, enrollment, and monitoring milestones  until study closeout.
• Developing and maintaining study documents including protocol and informed consent forms, study manuals, source documentation templates, recruitment materials and other study-specific tools and resources
• Designing case report forms and website.
• Collecting, reviewing and maintaining all required regulatory documents.
• Assisting sites with maintenance of regulatory documents and responding to study related questions from sites, vendors and sponsors in a timely fashion.
• Planning and execution of study-wide in-person and remote conference calls, meetings and trainings including scheduling, creation and distribution of agendas and supportive materials, technical support, recording summaries and summarizing and distributing action items.
• Monitoring study-wide metrics including recruitment goal attainment and identify impediments to success and propose solutions.
• Drafting and executing newsletters, presentations and other summaries of study-wide progress and metrics.
• Handling study budget related questions, invoicing vendor contracts, monitoring and reconciliation of financial expenditures.
• Travel to study-specific professional meetings as needed.

Accept responsibilities for additional tasks and responsibilities, as requested. Escalate issues to senior staff, as appropriate.

Qualifications:

• A bachelor's degree is required.
• At least one year of experience in research or a related field.
• Background/familiarity with biology or other scientific discipline is preferred, but not required.

Skills/Abilities/Competencies required:

• Knowledge of federal regulations relating to protection of human subjects and good clinical practice guidelines is preferred, but not required.
• Attention to detail, excellent organizational and analytical skills are required.
• Excellent computer skills working with Microsoft Office are required.
• Team player who can take direction to work independently in an extremely fast moving, deadline-driven environment, while balancing multiple tasks simultaneously.