Clinical Trial Assistant Project Manager

Mass General Brigham•Somerville, MA

3d•$63,253 - $102,596•Hybrid

About The Position

The Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital is an academic clinical research organization that manages clinical trials in neurological disorders. Reporting to a senior member of the project management team, the Assistant Project Manager supports the Project Manager in delivering assigned multicenter clinical research projects from initiation through implementation and close-out. The role assists with oversight of study scope, timelines, budgets, quality, resources, study and site management, vendor activities, and study meetings. It also contributes to regulatory and safety oversight, study documentation, site coordination, reporting, and communication with investigators, sponsors, vendors, and regulatory bodies. The position is hybrid, has a 40-hour scheduled workweek, and is based at 399 Revolution Drive.

Requirements

Bachelor’s degree required.
At least one year of experience in research or a related field required.
Knowledge of federal regulations relating to protection of human subjects and good clinical practice guidelines.
Attention to detail and excellent organizational and analytical skills.
Excellent computer skills, including experience working with Microsoft Office.
Ability to work as a team player, take direction, work independently in a fast-moving, deadline-driven environment, and balance multiple tasks simultaneously.

Nice To Haves

Two to three years of previous industry clinical trial experience preferred.
Background or familiarity with biology or another scientific discipline preferred, but not required.

Responsibilities

Collaborate with project investigators and research sites to meet study start-up, site activation, patient recruitment, and enrollment targets.
Develop study documents, including protocols, informed consent forms, study manuals, source documentation templates, recruitment materials, and other study tools.
Work with Data Management, Systems, and Biostatisticians on the design of case report forms, study portals, and electronic data capture systems.
Manage and report safety information to the FDA, Data and Safety Monitoring Boards, Medical Monitors, funding agencies, and other regulatory bodies.
Lead cross-functional teams in timely, high-quality clinical study execution, applying expertise and risk mitigation.
Build effective, high-performing teams through communication, decisiveness, and technical expertise.
Collect, review, and approve required regulatory documents and keep the study Trial Master File current and audit-ready.
Oversee IND/CTA applications and communications with regulatory agencies, including the FDA and Health Canada, for studies with investigator-held INDs/CTAs.
Assist sites with IRB submissions, regulatory document maintenance, and timely responses to study-related questions from sites, vendors, and sponsors.
Schedule study meetings, prepare agendas and minutes in collaboration with the study team, and lead meetings or calls as needed.
Tabulate key metrics for progress reports and presentations, and assist with preparing publications.
Prepare written summaries and other materials for internal and external communications, including CT.gov and the NEALS website, and for grant support such as funding updates and progress reports.
Review monitoring plans and track and review trip reports.
Work with Grants Management on study budget questions and invoicing, including site payments and vendor contracts.
Work with the PI and sponsor to assist in managing vendor activities.
Travel to national and international professional meetings as needed.
Escalate issues to the Project Manager responsible for assigned projects, as appropriate.
Take on additional tasks and responsibilities as requested.