Boston Scientific · 6 hours ago
Clinical Research Associate
US-MA-Marlborough
Full-time
Hybrid
Entry, Mid Level
$75K/yr - $143K/yr
2+ years expBoston Scientific is a leader in medical science, committed to solving the most important health industry challenges. The Clinical Research Associate (CRA) will support the Global Clinical Operations team in conducting clinical trial site start-up activities and ensuring compliance with regulatory standards.
Health CareMedicalMedical Device
No H1B
Responsibilities
Work independently and proactively to coordinate all necessary activities for site regulatory submissions and essential document collection for allocated clinical research sites
Manage multiple sets of essential regulatory documents across several studies and division portfolios
Partner with clinical sites to support the negotiation and customization of Informed Consent Forms (ICFs)
Develop and foster clinical research site relationships to become a subject matter expert in the site start-up regulatory process across multiple studies
Leverage knowledge of site regulatory processes and division priorities to meet clinical study goals and objectives
Manage to achieve target IRB/EC timelines by assisting clinical research sites with the application submission process and approval tracking
Manage and problem-solve site start-up challenges that arise to mitigate impact to service level agreements and study goals
Develop, prepare, complete, and track required regulatory, ICF, and legal documentation
Document clinical research site and investigator readiness for participation across multiple studies
Support internal quality audits and regulatory inspections, as applicable
Update and maintain study-specific start-up and close-out trackers
Update and maintain site-specific metrics in Clinical Trial Management Systems; file and maintain site documents in eTMFs
Provide updates to leadership on site start-up activities, investigator readiness, and regulatory submission/approval status
Escalate challenges and/or initiate outreach to principal investigators, clinical research site coordinators, divisional clinical study leads, and other stakeholders as appropriate
Ensure compliance with applicable regulatory requirements (e.g., ICH/GCP, MDR, GDPR) and internal SOPs/WIs, policies, and procedures
Qualification
Required
Bachelor's degree, or an equivalent combination of education and experience
Minimum of 2 years' experience in clinical/scientific research, including medical device clinical study site start-up experience within the US
Ability to support multiple studies and personnel simultaneously in a fast-paced environment
Strong written and verbal communication skills; comfortable interacting with clinical research site personnel via phone and email
Demonstrated ability to work independently and within a team environment
Preferred
Research Coordinator or In-House Clinical Research Associate / Clinical Research Associate / Study Start-up Specialist experience
Experience working with clinical trial management systems (e.g., Siebel CTMS, Veeva) and clinical document control systems / eTMF
Strong focus on customer service and stakeholder engagement
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$10.02B2025-02-21Post Ipo Debt· $1.58B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
2026-01-24
2026-01-23
Company data provided by crunchbase