Clinical Research Associate

Boston Scientific • Georgetown, MA

1d

About The Position

Your responsibilities will include: 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. Develop and foster clinical research site relationships to become a subject matter expert in the site start-up regulatory process across multiple studies. 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. Support internal quality audits and regulatory inspections, as applicable. Provide updates to leadership on site start-up activities, investigator readiness, and regulatory submission/approval status. Ensure compliance with applicable regulatory requirements (e.g., ICH/GCP, MDR, GDPR) and internal SOPs/WIs, policies, and procedures.

Requirements

• 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.
• IRB submissions and approvals
• Site informed consent form (ICF) customizations and negotiations
• Essential regulatory document collection

Nice To Haves

• 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.

Responsibilities

• Coordinate site regulatory submissions and essential document collection
• Manage essential regulatory documents across studies
• Develop clinical research site relationships
• Assist sites with IRB/EC application submission and approval tracking
• Problem-solve site start-up challenges
• Develop, prepare, complete, and track regulatory, ICF, and legal documentation
• Support internal quality audits and regulatory inspections
• Provide updates on site start-up activities and regulatory status
• Ensure compliance with regulatory requirements and internal procedures

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees