<span>Clinical Research Associate I</span>

Boston Scientific • Santa Clarita, CA

389d • Remote

About The Position

The Clinical Research Associate I role at Boston Scientific involves monitoring clinical studies to ensure the protection of subjects' rights and well-being, as well as the accuracy and completeness of reported study data. The position supports various phases of clinical trials, including start-up, enrollment, follow-up, and closure, while ensuring compliance with regulatory requirements and protocols.

Requirements

• Bachelor's degree in Life Sciences, Nursing, or a related field with 0-1 years of experience in clinical research monitoring or related roles.
• Strong understanding of GCP, ISO, and other applicable regulatory requirements.
• Proven ability to perform source verification and ensure data accuracy and completeness.
• Ability to travel approximately 75% of the time.

Nice To Haves

• Certification in Clinical Research (e.g., CCRP, CCRA) or equivalent.
• Familiarity with clinical trial management systems (CTMS) and electronic data capture (EDC) tools.
• Excellent written and verbal communication skills, with experience in report writing.
• Experience managing multiple projects or studies simultaneously, demonstrating strong organizational skills.

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, and study memos.
• Train site personnel to conduct clinical studies in accordance with protocols and regulations, maintaining training records.
• Address and document any identified non-compliance issues during monitoring visits and escalate as necessary.
• Identify, document, and report all reportable events per protocol and regulatory requirements.
• Participate in study-specific meetings and collaborate with cross-functional team members throughout all study phases.
• Manage study contracts and collect relevant investigator/site documentation, including budget negotiations.

Benefits

• Access to the latest tools, information, and training to advance skills and career.
• Support for progressing in career ambitions.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees