Remote Senior Clinical Research Associate – Trials

Accelcia Business Services; Northern (KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Establishment Labs is seeking a Senior Clinical Research Associate to manage and monitor clinical studies from start-up through closeout, ensuring compliance with GCP, ICH, FDA and global requirements. This role supports patient safety, data quality and regulatory activities in a remote setting.

You will coordinate sites, CROs, and cross-functional teams, travel domestically and internationally as needed, and contribute to inspections, audits and process improvements.

Qualifications

• Bachelor's degree in Life Sciences, Health Sciences, Nursing, Pharmacy, or related field (Master's preferred).
• 4+ years of clinical research in medical devices, pharma, CRO, or healthcare (Class III devices preferred).
• Strong knowledge of GCP, ICH, FDA regulations; CCRP/RAPS certification preferred.
• Experience with site monitoring, SDV, multi-site and international studies.
• Proficient with MS Office; CTMS/eTMF/EDC experience preferred.
• Willingness to travel domestically and internationally.

Responsibilities

• Coordinate and oversee clinical trial activities from study start-up through closeout.
• Conduct remote and on-site monitoring visits, including qualification, initiation, and routine monitoring.
• Ensure protocol compliance, data accuracy, SDV, and study quality.
• Maintain TMF/eTMF files and inspection-ready records.
• Support safety reporting: AEs/SAEs and follow-up actions.
• Collaborate with sites, CROs, vendors, and stakeholders to ensure study execution.
• Assist with regulatory submissions, FDA reporting, ClinicalTrials.gov updates, and post-market activities.
• Support audits, inspections, and quality initiatives; ensure regulatory compliance.
• Contribute to SOPs and process improvements in clinical operations.

Skills

GCP knowledge

ICH guidelines

Regulatory compliance

Communication

Travel willingness

Education

Bachelor's degree in Life Sciences or related field

Master's degree preferred

Tools

CTMS

eTMF

EDC

Job description

Establishment Labs is seeking a Senior Clinical Research Associate to manage and monitor clinical studies from start-up through closeout, ensuring compliance with GCP, ICH, FDA and global requirements. This role supports patient safety, data quality and regulatory activities in a remote setting.

You will coordinate sites, CROs, and cross-functional teams, travel domestically and internationally as needed, and contribute to inspections, audits and process improvements.