Clinical Trial Assistant Project Manager
About The Position
The Neurological Clinical Research Institute (NCRI) at the Massachusetts General Hospital (MGH) is a premier Academic Clinical Research Organization (CRO) managing clinical trials in neurological disorders. The NCRI employs physician clinical researchers, research nurses, project managers, data managers, SAS programmers, systems analysts, grants managers, and administrative assistants dedicated to planning and implementing clinical trials. Reporting to a senior member of the PM team, the Assistant Project Manager will be responsible for assisting the Project Manager in providing oversight and leadership necessary for the successful delivery of projects from initiation to implementation to close-out of assigned multi-center clinical research activities led by the NCRI. The Assistant Project Manager is expected to assist the Project Manager in effectively managing scope, schedule/timelines, budget, quality, and resources of the assigned trial(s). The Assistant Project Manager will also assist the Project Manager in study management, including outside clinical site management, vendor management, and study meeting planning and execution.
Requirements
- A bachelor’s degree is required.
- At least one year of experience in research or a related field.
- Knowledge of federal regulations relating to the protection of human subjects and good clinical practice guidelines.
- Attention to detail, excellent organizational and analytical skills.
- Excellent computer skills, working with Microsoft Office.
- Team player who can take direction to work independently in an extremely fast-moving, deadline-driven environment, while balancing multiple tasks simultaneously.
Nice To Haves
- Background/familiarity with biology or other scientific disciplines is preferred, but not required.
Responsibilities
- Collaborating with project investigators and research sites to ensure targets are met for study start-up, site activation, patient recruitment, and enrollment.
- Developing study documents including protocol and informed consent forms, study manuals, source documentation templates, recruitment material,s and other study tools.
- Working closely with Data Management, Systems, and Biostatisticians to assist with the design of case report forms, study portals, and electronic data capture systems.
- Safety management and reporting tothe FDA, Data and Safety Monitoring Boards, Medical Monitors, funding agencies, and other regulatory bodies.
- Leading cross-functional teams in the timely execution of high-quality clinical research studies, leveraging knowledge, expertise, and risk mitigation.
- Building effective, high-performance teams via expert communication, decisiveness, and technical expertise
- Collecting, reviewing, and approving all required regulatory documents; and working to ensure the study Trial Master File (TMF) is up to date and “audit ready” throughout the course of the study.
- Overseeing IND/CTA applications and communication with regulatory agencies (FDA, Health Canada, etc.) for studies with investigator-held INDs/CTAs.
- Assisting sites with IRB submissions, maintenance of regulatory documents, and responding to study-related questions from sites, vendors, and sponsors in a timely fashion.
- Scheduling and developing agendas and meeting minutes, in collaboration with the study team, for study-related meetings – both remote and in person, and leading meetings/calls as needed.
- Tabulating key metrics for progress reports, presentations, and assist in preparing publications.
- Preparing materials including written summaries for internal and external communication (CT.gov, NEALS website, etc) and grant support (funding updates, progress reports, etc).
- Reviewing monitoring plans, tracking, and reviewing trip reports.
- Working closely with Grants Management on study budget-related questions and invoicing (site payments, vendor contracts, etc).
- Working closely with the PI/ Sponsor, assist with the management of vendor activities
- Travel to national and international professional meetings as needed.
- Escalates issues to the Project Manager responsible for assigned projects, as appropriate
- Take on additional tasks and responsibilities, as requested.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
5,001-10,000 employees
