Operations and Regulatory Project Manager, BWH Center for Clinical Investigation, Hybrid

Mass General Brigham - Boston, MA

Full-time - Mid Level

Boston, MA

1,001-5,000 employees

Ambulatory Health Care Services

About the position

The Operations and Regulatory Project Manager at Brigham & Women's Hospital's Center for Clinical Investigation plays a crucial role in supporting clinical research projects. This position involves coordinating regulatory submissions, ensuring compliance with federal and state regulations, and acting as a liaison between study teams, sponsors, and regulatory bodies. The Project Manager is responsible for overseeing study start-up activities and maintaining regulatory documentation, contributing to the effectiveness of the clinical research enterprise.

Responsibilities

• Prepares and submits protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval.
• Prepares and submits regulatory documentation including IND/IDE applications and FDA annual reports to appropriate regulatory agencies.
• Maintains and organizes regulatory files for each assigned study in compliance with federal and local regulations.
• Maintains various regulatory tracking databases related to study recruitment and progress.
• Assists in the preparation and coordination of study monitoring and auditing visits.
• Performs Study Start Up Assessments of clinical research protocols prior to study initiation.
• Provides human research education at MGB institutions as assigned.
• Assists with the development of study management tools and document templates for the MGB research community.
• Tracks and manages assigned new protocol start-up packets to ensure benchmarks are met.
• Communicates and collaborates with clinical trial stakeholders throughout the start-up process.

Requirements

• Bachelor's degree (BA, BS) required.
• 3+ years of direct clinical research experience required.
• Knowledge of ICH/GCP guidelines is essential.
• Previous experience with clinical trials and/or research coordination and personnel management is required.

Nice-to-haves

• Experience in project management related to clinical research.
• Strong communication and listening skills.
• Ability to work effectively and collaboratively with a wide range of staff and interdisciplinary teams.

Benefits

• Health insurance coverage
• Dental insurance coverage
• 401k retirement savings plan
• Paid holidays
• Flexible scheduling options