Senior Clinical Research Associate: MedTech Trials Lead

NAMSA; United States; Hybrid; USD 69,000 - 134,000; Full time

Job summary

NAMSA in the United States is seeking an experienced Clinical Research Associate to monitor trials, ensuring GCP, regulatory compliance, and patient protection throughout site activities. You will coordinate site monitoring, conduct on-site and remote visits, manage study documents, training, and reports, and support audits and partner communications while traveling as required.

Excellent organizational skills and ability to work independently after training are essential, as is fluency in

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.

Responsibilities

• Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed.
• Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines.
• May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits.
• Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed.
• Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns.

Skills

Clinical trial experience

Monitoring experience

Verbal and written communication

Organizational skills

Independent worker

Education

Higher education degree

Job description

NAMSA in the United States is seeking an experienced Clinical Research Associate to monitor trials, ensuring GCP, regulatory compliance, and patient protection throughout site activities. You will coordinate site monitoring, conduct on-site and remote visits, manage study documents, training, and reports, and support audits and partner communications while traveling as required.

Excellent organizational skills and ability to work independently after training are essential, as is fluency in