Clinical Research Associate -Minneapolis, Minnesota

Responsibilities

• Conduct on-site and remote monitoring visits from SIV to COV, ensuring study sites adhere to protocols and regulatory requirements.
• Train investigators and site personnel on study protocols and best practices.
• Review Case Report Forms (CRFs) and verify entries against source documentation.
• Document site visits, findings, and follow-ups in detailed reports.
• Facilitate communication among investigative sites, sponsors, and internal teams.
• Identify and assess potential investigators in collaboration with sponsors.
• Ensure compliance with FDA, ICH-GCP, and local regulatory guidelines.
• Assist in study submissions and preparation of regulatory documents.
• Support project teams with study communications and trial management activities.

Qualifications

• 6+ years of experience in clinical trial monitoring for CROs and Sponsors, with a strong focus on medical device trials.
• Expertise in cardiology trials and experience across other therapeutic areas.
• Affiliation with higher or specialized degree in natural sciences (e.g., Biology, Medicine, Pharmacy, or related fields).
• CRA Certification with a track record of successful monitoring visits.
• Proficiency in electronic CRF (eCRF), CTMS systems, and other digital tools.
• Background in CROs, pharmaceuticals, biotechnology, and medical devices.
• Fluency in English (a second language is a plus).
• Willingness to travel as required for site visits and monitoring activities.