MGH & BWH Center for Clinical Data Science

Project Coordinator - (3285080)

Description

GENERAL SUMMARY/ OVERVIEW STATEMENT: 

The mission of the MGH Clinical Translational Research Unit Core is to support investigators in the discovery, development, and implementation of promising therapeutics and associated diagnostics for individuals with complex brain disorders affecting cognition, behavior, emotion, sensory and motor functioning, and other diseases as related to the brain. Under the general supervision of the CTRU Core Program Director, the Clinical Research Project Coordinator is responsible for all aspects of project coordination for clinical and translational trials and/or studies and/ or projects for a large group of investigators representing the MGH Martinos Center for Biomedical Imaging and the MGH Departments of Neurology, Psychiatry and Radiology. 

They will liaise with study sponsors, CROs, funding agencies, central vendors, as well as all levels of study staff of the CTRU to ensure the smooth operation of assigned MGH and multi-site clinical trials and translational research projects. Responsibilities also include participation in developing and maintaining best practice guidelines, study tool templates, Standard Operating Procedures, as well as conducting staff trainings and advising/mentoring junior staff members. The incumbent will also participate in planning and implementing training programs for multi-disciplinary staff, as needed. The incumbent should display a high degree of initiative and independent judgment to continually assess and direct a wide range of projects and program issues, including clinical translational research operations, project development and research compliance.

The Project Coordinator will be responsible for providing oversight and leadership necessary for successful delivery of projects from initiation and implementation to close-out of assigned multi-center research activities. The Project Coordinator is expected to contribute to schedule/timelines, budget, quality control and resource allocation of the assigned projects.

PRINCIPAL DUTIES AND RESPONSIBILITIES: 

Primary responsibilities include, but are not limited to:

• Is responsible for the CTRU billing and invoicing and helps manage the revenue flow for CTRU accounts.
• Assures compliance with federal purchase and contract requirements.
• Indirect supervision of 3-4 Study Coordinators, including hands‐on training, regular mentorship, and assisting triage of day‐to‐day workload
• Collaborate with CTRU leadership, team members and administrative and clinical leaders across the research community to support standard project implementations, including change management strategies.
• Develop, communicate, and hold assigned project staff accountable for project timelines, key performance indicators, and project deliverables.
• Collaborate with clients and stakeholders to ensure deliverables are met, including serving as point person for project team to evaluate and present issues for escalation.
• Collaborate with leadership to identify, evaluate and recommend new techniques, tools and strategies for project management as well as operational improvements for the department
• Create and make available to project management staff advanced project management tools, workflows and documentation. Train others in their use and application.

SUPERVISORY RESPONSIBILITY: 

Staff Supported: 3-4 Clinical Research Coordinators 

Non-Employees: 1-3 co-ops

WORKING CONDITIONS: 

Incumbent will have a workspace in Building 149 in the Charlestown Navy Yard and will be equipped with a networked computer. The successful applicant may be expected to work from home at times and will be provided with the necessary technology/equipment to allow this. 

Primary Location: USA-MA-Charlestown Work Locations: 149 13th Street Charlestown 02129

Qualifications

SKILLS & COMPETENCIES REQUIRED: 

• Excellent leadership, presentation and writing skills.
• Ability to make independent effective decisions.
• Ability to identify issues across studies and propose solutions.
• Outstanding communication (oral and written) and interpersonal skills.
• Ability to develop and manage positive relationships with both academic and industry sponsor representatives.
• Ability to lead study team and provide guidance and supervision to all members of the study team as needed.
• In-depth understanding of Good Clinical Practice guidelines and relevant FDA regulations, and the ability to implement these principles appropriately, and advise study team members on implementation.
• In-depth understanding of the role of study monitors/CRAs and ability to provide supervision/oversight to the monitoring team, as appropriate.
• Ability to manage multiple studies and provide indirect supervision/mentoring to CRCs as needed.
• Experience writing and submitting protocols to regulatory agencies (FDA, IRBs, etc), and knowledge of regulatory processes.
• Ability to develop and manage positive relationships with sponsor representatives (academic and industry based), study team members and other vendors.

EDUCATION: 

Bachelor's Degree required.

EXPERIENCE: 

3 years of relevant research and/or admin work experience required.

EEO Statement 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

: MA-Charlestown-MGH 529 Main

Work Locations

: 

MGH 529 Main 

529 Main Street 

Charlestown 02129

Job

: Professional/Managerial

Organization

: Massachusetts General Hospital(MGH)

Schedule

: Full-time

Standard Hours: 40

Shift

: Day Job

Employee Status

: Regular

Recruiting Department: MGH Neurology Research

Job Posting

: Apr 8, 2024

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