Senior Clinical Research Associate

Whoop - Boston, MA

Full-time - Mid Level

Boston, MA

Repair and Maintenance

About the position

As a Senior Clinical Research Associate (CRA) at WHOOP, you will play a pivotal role in managing clinical trials from initiation to close-out. Your responsibilities will include ensuring projects are executed efficiently, within budget, and in compliance with regulatory guidelines. You will lead site management, remote monitoring, and communication between stakeholders to facilitate seamless trial execution, while overseeing site activities and maintaining adherence to protocols and regulations.

Responsibilities

• Manage all aspects of site activities, including site selection, initiation, monitoring, and close-out visits, ensuring adherence to protocol and regulatory requirements.
• Oversee and perform remote site management, ensuring data integrity, protocol compliance, and timely reporting.
• Train investigators and site staff on protocol, study objectives, and regulatory requirements.
• Develop study plans, including timelines, budgets, and resources, and ensure their alignment with project objectives.
• Assist in the preparation, submission, and follow-up of regulatory documents, including IRB submissions, protocol amendments, and safety reporting.
• Proactively identify potential risks and implement mitigation strategies to ensure smooth trial execution.
• Maintain clear and proactive communication with sponsors, investigators, and cross-functional teams to ensure alignment and resolve any issues promptly.
• Ensure that all site data and documentation are accurate, complete, and in compliance with Good Clinical Practice (GCP) and regulatory standards.
• Oversee site close-out processes, ensuring all study-related documentation is reconciled and submitted on time.

Requirements

• Bachelor's degree in Life Sciences, Clinical Research, or a related field.
• 3+ years of experience in clinical research, with a focus on clinical trial management and site monitoring.
• Strong knowledge of FDA regulations, ICH-GCP guidelines, and international clinical research requirements.
• Proven ability to manage multiple sites and complex clinical trials, both remotely and on-site.
• Excellent organizational skills, with the ability to manage timelines, budgets, and project deliverables.
• Strong written and verbal communication skills, with the ability to collaborate across teams and manage stakeholders.
• Experience with clinical trial management systems (CTMS) and electronic data capture (EDC) systems.

Benefits

• Diverse and inclusive work environment
• Opportunities for professional growth and development
• Relocation assistance for candidates moving to Boston, MA