Clinical Research Associate III

Boston Scientific • Spencer, IN

436d

About The Position

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

Requirements

• Bachelor's degree in Life Sciences, Nursing, or a related field with 2-4 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 50% 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

• Competitive salary
• Access to the latest tools and training for career advancement
• Support for professional development and skills progression

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree