In-House Clinical Research Associate II

About the role

Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.

Responsibilities

• Coordinate site regulatory submission activities and essential document collection for assigned clinical research sites across multiple studies and division portfolios.
• Manage multiple site start-up activities and regulatory document workflows simultaneously while supporting study timelines and milestones.
• Partner with clinical research sites to support informed consent form customization, negotiation, and related documentation.
• Support IRB and Ethics Committee application submissions, approval tracking, and timeline management to achieve study start-up objectives.
• Develop, prepare, complete, and track required regulatory, informed consent, and legal documentation.
• Build collaborative relationships with clinical research sites and serve as a trusted resource throughout the site start-up process.
• Document investigator and site readiness to support participation across multiple clinical studies.
• Update and maintain study-specific start-up and closeout trackers, site metrics within Clinical Trial Management Systems, and documentation within electronic Trial Master File (eTMF) systems.
• Provide regular updates to leadership regarding site start-up progress, investigator readiness, regulatory submissions, approvals, risks, and timelines.
• Identify and escalate site start-up challenges while coordinating with principal investigators, site coordinators, clinical study leads, and other stakeholders to resolve issues.
• Support enrollment, follow-up, and study closeout activities, as applicable.
• Support internal quality audits and regulatory inspections while ensuring compliance with ICH/GCP, MDR, GDPR, internal standard operating procedures, work instructions, policies, and applicable regulatory requirements.

Requirements

• Bachelor's degree in a clinical, scientific, healthcare, life sciences, or related field, or an equivalent combination of education and relevant experience.
• Minimum of 3 years' experience in clinical or scientific research, including clinical study site start-up activities within the United States.
• In lieu of a bachelor's degree, minimum of 7 years' experience in clinical research, clinical study operations, site start-up, regulatory documentation, or related healthcare or life sciences experience.
• Proven experience supporting regulatory document collection, IRB or Ethics Committee submission processes, informed consent documentation, and clinical trial site readiness activities.
• Demonstrated experience managing multiple studies, regulatory document workflows, and competing priorities in a fast-paced environment.
• Demonstrated experience communicating professionally with clinical research site personnel through phone, email, and other communication channels.
• Working knowledge of applicable clinical research regulations and standards, including ICH/GCP, MDR, GDPR, internal standard operating procedures, work instructions, policies, and procedures.
• Strong collaboration, organization, written communication, and project management skills desired.