Clinical Trial Assistant Project Manager

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.

Job Summary

Principal Duties and 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 materials 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 to 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 of 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 meeting - 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 and tracking and review of trip reports.
• Working closely with Grants Management on study budget related questions and invoicing (site payments, vendor contracts, etc).
• Working closely with PI/ Sponsor assist with management of vendor activities
• Travel to national and international professional meetings as needed.
• Escalating issues to Project Manager responsible for assigned projects, as appropriate.
• Taking on additional tasks and responsibilities, as requested.

Qualifications:

• A bachelor's degree is required.
• At least one year of experience in research or a related field required; previous industry clinical trial experience 2-3 years preferred.
• 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.
• 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.

Pay Range

Grade