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Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.
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Job Summary
Working closely with principal investigators and departmental research leadership, the Clinical Research Project Manager coordinates and manages the day-to-day operations of a portfolio of clinical research studies, including NIH-funded, industry-sponsored, and investigator-initiated studies and clinical trials. The position is responsible for operational implementation of research protocols at one or multiple sites, from study development and activation through conduct and closeout. The Project Manager executes procedural, managerial, and policy decisions for assigned studies; contributes to study planning and continuous improvement; oversees study budgets and operational resources; and participates in grant and research proposals. The role provides hands-on coordination and leadership to multidisciplinary research teams while maintaining high standards for participant safety, regulatory compliance, data quality, and clinical workflow integration.
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Qualifications
Essential Functions
- Manage NIH-funded, industry-sponsored, and investigator-initiated clinical research studies and trials from start-up and activation through implementation, monitoring, reporting, and closeout, including multi-site studies as assigned.
- Work with principal investigators, research nurses, clinical teams, and departmental leadership to translate protocols into operational plans, coordinate study activities, and integrate research into NICU, neonatal, postpartum, and related clinical workflows.
- Coordinate regulatory submissions and essential study documentation, including IRB approvals, amendments, continuing review, training records, and study files; promote adherence to protocols, Good Clinical Practice (GCP), HIPAA, institutional policies, and applicable sponsor and federal requirements.
- Oversee participant screening, recruitment, eligibility tracking, informed-consent workflows, scheduling, retention, and follow-up, with particular attention to patient preferences and sensitive interactions with newborns and families.
- Serve as a key operational contact for NIH and industry sponsors, contract research organizations, collaborating institutions, vendors, and study sites; coordinate site communications, monitoring visits, audits, deliverables, and corrective actions.
- Develop and oversee study budgets, staffing plans, expenditures, and resource needs; coordinate with research administration and finance on industry trial budgets, sponsor payments, invoicing, research billing, and financial reporting as applicable.
- Contribute to grant applications, renewals, progress reports, industry proposals, and study agreements by preparing operational plans, timelines, staffing estimates, budgets, performance metrics, and other required materials.
- Provide day-to-day leadership, onboarding, training, mentorship, and workload coordination for research assistants, coordinators, and other study staff; supervise assigned personnel and promote consistent research practices as applicable.
- Oversee study data collection, quality review, secure recordkeeping, and research logistics, including EHR-based screening tools, databases, supplies, equipment, and biospecimen collection, tracking, and shipment.
- Develop and improve standard operating procedures, study workflows, and tracking systems; monitor enrollment, milestones, compliance, and operational risks, and provide timely status updates and recommendations to investigators and departmental leadership.
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Education Qualifications
- Bachelor's Degree in Related Field of Study required
Experience Qualifications
- 3-5 years Research Related Experience required
Can this role accept experience in lieu of a degree?
No
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Additional Job Details (if applicable)
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Remote Type
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Work Location
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Scheduled Weekly Hours
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Employee Type
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Work Shift
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Pay Range
$63,252.80 - $102,596.00/Annual
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Grade
7
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EEO Statement:
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Mass General Brigham Competency Framework
At Mass General Brigham, our competency framework defines what effective leadership ālooks likeā by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
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