Sr. Clinical Research Associate

About the position

The Senior Clinical Research Associate at Boston Scientific is responsible for monitoring clinical studies at the site level, ensuring the protection of subjects' rights and well-being, and verifying the accuracy and completeness of reported study data. This role involves supporting various phases of clinical trials, including startup, enrollment, follow-up, and closure, while adhering to regulatory requirements and protocols.

Responsibilities

• Conduct source verification by comparing data on Case Report Forms against source documents and verifying Informed Consent Forms for accuracy and completeness.
• Ensure clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos, and general correspondence.
• Train site personnel to ensure they are prepared to conduct the clinical study in accordance with protocol and applicable regulations.
• Address and document any identified non-compliance issues, and support regulatory inspection activities as required.
• Identify, document, and report all reportable events per protocol and applicable regulations.
• Participate in study-specific meetings, teleconferences, and trainings, collaborating with cross-functional team members and study sites throughout all study phases.
• Manage study contracts and request/collect relevant investigator/site documentation, including budget negotiations.

Requirements

• Bachelor's degree and/or equivalent combination of education and experience
• 3-5 years of clinical research experience and monitoring experience

Nice-to-haves

• Experience monitoring device studies
• Medical device experience and knowledge of applicable clinical research regulations (FDA, GCP, ISO)
• Strong communication and organizational skills

Benefits

• Competitive salary
• Access to the latest tools, information, and training for career advancement