Senior MedTech Clinical Trials Monitor

North American Science Associates, Inc.; United States; Hybrid; USD 69,000 - 134,000; Full time

Job summary

NAMSA is seeking a Clinical Research Associate to support assigned studies, ensuring human subject protection and GCP compliance across sites. You will coordinate monitoring activities, serve as primary site liaison, and help manage study documents and regulatory submissions.

The role involves on-site and remote monitoring, attendance at meetings, and supporting training and audits. Strong communication and organizational skills are essential.

Qualifications

• Higher education degree or equivalent education, training, and experience.
• Fluency in English and local language is required.
• Strong verbal and written communication skills.
• Good organizational skills and basic computer proficiency.
• Understanding of clinical research processes and regulations.

Responsibilities

• Work on assigned studies to ensure human subject protection and GCP compliance.
• Coordinate and manage clinical site monitoring per contracts and SOPs.
• Conduct on-site and remote site qualification, initiation, interim and close-out visits.
• Serve as primary contact for site questions on enrollment, conduct, and close-out.
• Communicate site performance, trends, deficiencies and concerns to the study team.
• Support start-up activities, tracking and quality review of study documents.
• Perform study-related training and maintain study documents and systems.
• Ensure quality of master files and track required documents.
• Track study metrics: enrollment, deviations, adverse events, TMF maintenance.
• Attend meetings and provide progress reports and visit documentation.
• May support safety activities and regulatory submissions.
• Assist in site budget and contract negotiations and audits.
• Support data management, CRF development, validation, and reporting.
• Register trials on Clinicaltrials.gov.

Skills

Fluency in English

Local language fluency

Good communication

Strong organizational skills

Basic computer skills

Understanding of clinical research

Education

Higher education degree

Tools

SoCRA Certification

ACRP Certification

Job description

NAMSA is seeking a Clinical Research Associate to support assigned studies, ensuring human subject protection and GCP compliance across sites. You will coordinate monitoring activities, serve as primary site liaison, and help manage study documents and regulatory submissions.

The role involves on-site and remote monitoring, attendance at meetings, and supporting training and audits. Strong communication and organizational skills are essential.