Clinical Trial Assistant Project Manager - Remote Eligible
Company: Massachusetts General Physicians' Organization
Posted on: September 25, 2022
Job Description - Clinical Trial Assistant Project Manager -
Remote Eligible (3213675) Clinical Trial Assistant Project Manager
- Remote Eligible - ( 3213675 ) 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 on providing oversight and leadership
necessary for 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 Manger will also assist
the Project Manager in study management, include outside clinical
site management, vendor management, and study meeting planning and
execution. PRINCIPAL DUTIES AND RESPONSIBILITIES: - Responsible for
tasks relevant to the scope of assigned projects:
- 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
- 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
- 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
- Working closely with Grants Management on study budget related
questions and invoicing (site payments, vendor contracts,
- Working closely with PI/ Sponsor assist with management of
- 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
- At least one year of experience in research or a related
- Background/familiarity with biology or other scientific
discipline is preferred, but not required. SKILLS/ ABILITIES/
- Knowledge of federal regulations relating to protection of
human subjects and good clinical practice guidelines.
- Attention to detail, excellent organizational and analytical
- 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. WORKING CONDITIONS: - This role has
established a long-term and sustainable, structured, flexible
workplace program that allows both in-office and off-site work.
In-office is standard office conditions. An employee's primary
residence is expected during working days for off-site work and
must comply with institutional confidentiality requirements. There
may be travel on public roads and air travel as needed. SUPERVISORY
RESPONSIBILITY: - None. - FISCAL RESPONSIBILITY: - No direct
responsibility, but may assist project managers to track site
payments according to grant budgets, as needed. Massachusetts
General Hospital is an Equal Opportunity Employer. By embracing
diverse skills, perspectives and ideas, we choose to lead.
Applications from -protected veterans and individuals with
disabilities are strongly encouraged. Primary Location Work
Locations MGH 165 Cambridge 165 Cambridge Street Job
Research-Management Organization Massachusetts General
Hospital(MGH) Schedule Full-time Standard Hours 40 Shift Day Job
Employee Status Regular Recruiting Department MGH Neurology
Keywords: Massachusetts General Physicians' Organization, Cambridge , Clinical Trial Assistant Project Manager - Remote Eligible, Executive , Cambridge, Massachusetts
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