| The project manager will be responsible for all aspects of the management and conduct of multiple biomedical and/or social-behavioral research studies, including clinical trials, reporting to the study PIs. This role manages all activities associated with these studies that could include multiple research teams, sites, participants, interventions, and assessments. Oversees day-to-day operations including identifying and securing needed resources; creating, implementing, monitoring, and updating project plans (e.g., manual of operating procedures, case report forms); preparation, submission, and update of regulatory documents (e.g., IRB); facilitating meetings; tracking tasks/deliverables to ensure timelines, milestones and/or goals are attained; monitoring and reporting progress as appropriate. This role will also be responsible for participant recruitment, screening, communications, scheduling, and may involve participant assessments and biospecimen handling. Ensures that all study activities are completed by strictly following BU/BUMC IRB, Good Clinical Practices (GCP), and all current local, state, and federal laws, regulations, guidance, policy and procedures, as applicable. The role will require presence at BU College of Health and Rehabilitation Sciences: Sargent College and BU School of Medicine on specific days each week. Duties and Responsibilities: - Direct and manage project development from beginning of project lifecycle to end
- Develop, implement, and monitor project protocols (e.g., MOOP, CRFs)
- Oversees completion of study activities per protocol
- Develop, submit, amend, and track regulatory submissions (e.g., BU/BUMC IRB)
- Liaise with clinical monitoring team and ensure timely completion of monitoring activities
- Purchases supplies, materials, equipment, and services
- Interact with study participants for screening, scheduling, and ongoing adherence
- Manage participant recruitment via multiple sources including but not limited to advertising in print and digital media, local physician practices, BMC clinical data warehouse, and third-party recruitment services
- Identify and build relationships with community partners for recruitment and/or intervention sites
- Be responsible for managing/handling biospecimens as needed
- Train, direct, assign duties to and may supervise members of research team
- Train junior project managers
- Attend project meetings and deliver project updates as required
- Effectively communicate project expectations to team members and stakeholders in a timely and clear fashion.
- Liaise with project stakeholders on an ongoing basis
- Delegate tasks and responsibilities to appropriate personnel
- Identify and resolve issues and conflicts within the project team
- Develop and deliver progress reports
- Coach, mentor, motivate, and supervise project team members and contractors, and apply soft persuasion skills for them to take positive action and accountability for their assigned work
- Perform other duties as required for the success of the project
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