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Clinical Research Program/Project Manager

Massachusetts General Hospital
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The Clinical Research Program/Project Manager will work at The MGH Mukerji Lab for Neuroinfectious Diseases. The incumbent is a highly organized individual with clinical observational studies or clinical trial research experience and serves as a Research Program/Project Manager. They will work with a multidisciplinary team from Mass General Brigham, alongside collaborators from Harvard Medical School, the University of San Francisco, Yale, and other national sites. The research efforts are typically (but not exclusively) focused on people with HIV or neurological infectious diseases. The Research Program/Project Manager will work under the direction of the Principal Investigator (PI) and play a key role in writing and preparing manuals, generating resources for patients and staff, assisting the PI in coordinating clinical trials and other clinical research activities, training staff, and potentially contributing to projects as a researcher, if interested. The incumbent may participate in all phases of research projects, from conception and design of studies to analysis and writing manuscripts for submission to academic journals. They will work with other team members, including Research Assistants (i.e., Lab Technicians, Clinical Research Coordinators), Visiting Research Scholars, and Clinical Study Physicians, Fellows, and Residents. 

PRINCIPAL DUTIES AND RESPONSIBILITIES:
Lab Management
  • Works under the supervision of the PI to oversee research portfolio of up to 3 research projects
  • Supervise, coach, and develop research assistants (research coordinator and lab technician), including: 
  • Develop curriculum and deliver new employee onboarding training 
  • Provide daily oversight and direction 
  • Meet regularly with research assistants
  • Participate in recruitment of research assistants 
  • Work with PI and Vaccine & Immunotherapy Center Lab Manager to manage clinical samples for ongoing research projects, including:
  • Managing supplies, inventory and organization of capital equipment (i.e., freezer) 
  • Building and maintaining biospecimen inventory using local software 
  • Ensure lab safety protocols for personnel, collaborating with Vaccine and Immunotherapy Lab Manager and under the supervision of the PI
Research Project Management
  • ​​​​​​​Oversees meeting plans of clinical trial and cohort studies, including:
  • Writing operations manuals and preparing clinical trial protocols, amendments, CRFs, IRB/Ethics applications, and recruitment materials
  • Reports study progress at stakeholder meetings (clinical team, DSMB, laboratory team)
  • Generates specific study documents, e.g., informed consent forms, study guidelines, operations manuals, training materials
  • Reviews action plans to address protocol compliance, safety, data 
  • Participates with the PI in the preparation of presentations of trial data for internal and external parties (management review, scientific meetings, and advisory boards)
  • Acts as the liaison between clinical trials pharmacy, statistician, neuroimaging, and lab specimen teams
  • Monitors drug accountability logs
  • Coordinate administrative and regulatory aspects of active and pending projects
  • Throughout the project duration, plan, track, and report on project tasks, responsible parties, timelines, etc.
  • Works under the direction of the PI to ensure research quality by closely monitoring adherence to research protocols for each project in the management portfolio
  • In conjunction with the PI, coordinate and monitor Institutional Review Board applications and reporting for projects, including all applicable review dates and deadlines to prevent lapses in approval
  • Oversee REDCap databases, including managing the design of data collection forms, extraction and uploading of datasets, and creation of reports for each project
Research (optional)
  • Contribute directly to and/or lead scientific analysis, abstract submissions, and manuscript development for 1-2 projects at a time 

SKILLS/ABILITIES/COMPETENCIES REQUIRED:  
Planning, Organizing, and Coordinating 
  • Skilled in identifying opportunities to improve the efficiency of research operations and subsequently execute improvements 
  • Time management skills with the capability to prioritize requests 
  • Strong budget management skills
Team Management 
  • Ability to work successfully in a collaborative environment 
  • Ability to effectively supervise and train staff
Results Oriented
  • Ability to make independent effective decisions
  • High personal work standards and sense of urgency about results 
  • Problem-solving ability, including the ability to gather information, identify resources, and imagine alternatives 
  • Demonstrates initiative and identifies key priorities, even in ambiguous situations with limited direction 
  • Strong database management and overall computer skills
  • Consistently demonstrates a positive, "can-do" attitude 
Communication Skills 
  • Excellent written and verbal communication skills 
  • Ability to represent the Neuroinfectious Diseases Lab with the utmost professionalism and ability to build strong relationships inside and outside the group 


QUALIFICATIONS: 
  • BA/BS required; Master’s Degree in public health, management, or related field preferred
  • 5+ years of experience in an academic, research, or related setting required
  • Experience in clinical trial settings strongly preferred
  • Prior supervisory experience strongly preferred