Clinical Research Project Manager

Mass General Brigham•Boston, MA

21h•$63,253 - $141,939•Hybrid

About The Position

The Clinical Research Project Manager oversees ongoing and new research projects within the MGH Resilience and Prevention Program (RAPP) and the Emotion and Social Neuroscience Laboratory (ESNL), based at the Martinos Center for Biomedical Imaging and the MGH Psychiatry Department. RAPP develops and tests psychosocial interventions intended to increase emotional resilience in youth at risk for serious mental illnesses. ESNL studies neural correlates of emotion and social cognition abnormalities in people affected by or at risk for serious mental illnesses. The work spans clinical intervention, prevention, neuroscience, and outcomes research, including multi-site studies and randomized controlled trials. The position manages multiple clinical studies and directly hires, supervises, and trains Clinical Research Coordinators and other study staff. It coordinates trial initiation, recruitment, study start-up, intervention procedures and fidelity, longitudinal data collection, and study workflows. The role may include building and quality-assuring REDCap instruments and case report forms, coordinating data requests, and reviewing data quality. It leads regulatory activity, including IRB submissions and ongoing reviews, and maintains regulatory documentation and compliance with applicable guidelines and sponsor requirements. The Project Manager also manages program and project plans, schedules, budgets, reports, and stakeholder communications; identifies risks and recommends mitigation strategies; and supports alignment with organizational goals. The position reports directly to the Principal Investigator and works closely with senior program managers, postdoctoral fellows, coordinators, and research and clinical operations partners. The role is full-time, hybrid, and scheduled for 40 hours per week on the day shift.

Requirements

Bachelor's degree in a related field is required.
Research-related experience of 5–7 years is preferred.
Supervisory experience of 1–2 years is preferred.
Ability to make independent, effective decisions.
Strong organizational and communication skills.
Ability to effectively supervise and train staff.
Strong database management and computer skills, including REDCap, Microsoft Suite, R, and Python.
Demonstrated analytical and problem-solving skills.

Nice To Haves

Master's degree or above, such as MS, MA, MPH, MPP, or equivalent.
At least 2 years of experience at managerial levels working in clinical research or grant coordination.
Experience working in MRI environments; applicable but not required.
Interest in community-based mental health interventions, clinical neuroscience, prevention of mental health conditions in at-risk youth, and outcomes research.

Responsibilities

Manage multiple ongoing and new clinical research studies across RAPP and ESNL, including multi-site studies and randomized controlled trials.
Directly hire, supervise, train, and support Clinical Research Coordinators and other study staff.
Coordinate trial initiation, patient recruitment, project approval, and study start-up.
Oversee clinical intervention and neuroimaging research protocols, including subject recruitment, intervention procedures, and fidelity.
Create, manage, and quality-assure standard operating procedures, study workflows, recruitment timelines, and longitudinal data-collection events.
Build REDCap instruments and case report forms with validation and branching logic, as needed; coordinate clinical-site data requests and review data quality.
Lead regulatory work for IRB submissions, modifications, continuing reviews, reportable new information, and consent revisions.
Maintain the study regulatory binder under single-IRB oversight at MGB and ensure compliance with federal, state, and sponsor requirements, audits, and progress reports.
Develop and maintain project schedules, budgets, and project plans; monitor progress and address deviations from plans, timelines, or budgets.
Identify program risks, issues, and challenges and develop mitigation strategies; escalate issues and recommend solutions.
Lead communication and collaboration with stakeholders, including sponsors, IRB, core laboratories, site principal investigators, study staff, research management, the Clinical Trials Office, MGB Healthcare Finance, and scientific collaborators.
Conduct research, manage data in systems, and prepare reports and presentations to support programs.
Write operations manuals and participate in developing policies and procedures for studies.
Coordinate multi-site trials with NIH, FDA, and private foundations.
Report study progress at investigators' meetings and provide regular updates to program leadership.
Coordinate and delegate cross-project initiatives and provide guidance and support to administrative team members.
Develop advertising strategies to support recruitment activities.