Lead Clinical Research Associate, MedTech Trials

North American Science Associates, Inc.; Northern (KY); Hybrid; USD 69,000 - 134,000; Full time

Job summary

NAMSA is seeking a Clinical Research Associate to ensure human subject protection and regulatory compliance across assigned studies. You will coordinate site monitoring, conduct on-site and remote visits, and serve as the primary contact for enrollment and conduct issues.

The role requires independent work, strong communication, and solid knowledge of GCP and clinical research processes. Up to 20% travel, with potential for onsite support and audits.

Qualifications

• Fluency in English and local language, if different, required.
• Higher education degree or equivalent education, training, and experience.
• Preferred 5 years clinical trial experience.
• Preferred 3 years monitoring experience.
• Preferred 1 year device trial experience.
• Able to work independently once trained.
• Good verbal and written communication skills.
• Strong organizational skills.
• Basic computer proficiency.
• Understanding of clinical research processes and regulations.
• Certifications such as SoCRA or ACRP preferred but not required.

Responsibilities

• Monitor studies to ensure human subjects protection, GCP, and regulations.
• Coordinate site monitoring responsibilities per agreements and SOPs.
• Conduct on-site and remote site qualification and monitoring visits.
• Serve as primary contact for site inquiries on enrollment and conduct.
• Communicate site performance, trends, deficiencies, and concerns.
• Support study start-up activities and quality review of documents.
• Perform study-related training and maintain study documents and systems.
• Track study metrics and maintain master files and TMF.
• Assist with audits, budgets, and contract negotiations as directed.
• Register trials on ClinicalTrials.gov.

Skills

Fluency in English

Excellent verbal and written comms

Strong organizational skills

Independent work ethic

Clinical research knowledge

Education

Higher education degree

Tools

Basic computer proficiency

Job description

NAMSA is seeking a Clinical Research Associate to ensure human subject protection and regulatory compliance across assigned studies. You will coordinate site monitoring, conduct on-site and remote visits, and serve as the primary contact for enrollment and conduct issues.

The role requires independent work, strong communication, and solid knowledge of GCP and clinical research processes. Up to 20% travel, with potential for onsite support and audits.