Massachusetts General Physicians’ Organization
Clin Trial Asst Proj Manager
Massachusetts General Physicians’ Organization, Boston, Massachusetts, us, 02298
Job Description - Clinical Trial Assistant Project Manager (3302936)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 the 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.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 the 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, and presentations, and assisting 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 to assist with the management of vendor activities.Travel to national and international professional meetings as needed.Escalates issues to Project Manager responsible for assigned projects, as appropriate.Take 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.Background/familiarity with biology or other scientific discipline is preferred, but not required.Skills/Abilities/Competencies Required:
Knowledge of federal regulations for protecting human subjects and good clinical practice guidelines.Attention to detail, and excellent organizational and analytical skills.Excellent computer skills working with Microsoft Office.Team player who can take direction to work independently in a swift-moving, deadline-driven environment, while balancing multiple tasks simultaneously.Working Conditions:
Standard Office conditions. Will travel on public roads and air travel as needed.Primary Location:
MGH Main Campus, 55 Fruit Street, Boston, 02114Job:
Research-ManagementOrganization:
Massachusetts General Hospital (MGH)Schedule:
Full-time, Standard Hours: 40Shift:
Day JobEmployee Status:
RegularRecruiting Department:
MGH Neurology Research
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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 the 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, and presentations, and assisting 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 to assist with the management of vendor activities.Travel to national and international professional meetings as needed.Escalates issues to Project Manager responsible for assigned projects, as appropriate.Take 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.Background/familiarity with biology or other scientific discipline is preferred, but not required.Skills/Abilities/Competencies Required:
Knowledge of federal regulations for protecting human subjects and good clinical practice guidelines.Attention to detail, and excellent organizational and analytical skills.Excellent computer skills working with Microsoft Office.Team player who can take direction to work independently in a swift-moving, deadline-driven environment, while balancing multiple tasks simultaneously.Working Conditions:
Standard Office conditions. Will travel on public roads and air travel as needed.Primary Location:
MGH Main Campus, 55 Fruit Street, Boston, 02114Job:
Research-ManagementOrganization:
Massachusetts General Hospital (MGH)Schedule:
Full-time, Standard Hours: 40Shift:
Day JobEmployee Status:
RegularRecruiting Department:
MGH Neurology Research
#J-18808-Ljbffr