Senior Clinical Research Associate

About the role

Establishment Labs, the world’s fastest‑growing women’s health company, is seeking a Senior Clinical Research Associate to lead and monitor clinical studies for its innovative medical aesthetic devices. The role ensures compliance with protocols, GCP, ICH and FDA regulations while supporting patient safety and high‑quality data across multi‑site, international trials.

Key responsibilities

• Coordinate clinical trial activities from start‑up through closeout, including site qualification, initiation, routine monitoring and closeout visits.
• Perform remote and on‑site monitoring, verify source documents, ensure protocol adherence and data accuracy.
• Maintain trial master file (TMF/eTMF) and inspection‑ready documentation.
• Support safety reporting for adverse events and serious adverse events.
• Collaborate with investigative sites, CROs, vendors and internal teams to drive successful study execution.
• Assist with regulatory submissions, FDA reporting, ClinicalTrials.gov updates and post‑market clinical activities.
• Support audits, inspections and quality initiatives, and contribute to SOP development and process improvements.

Required profile

• Bachelor’s degree in Life Sciences, Health Sciences, Nursing, Pharmacy or related field (Master’s preferred).
• 4+ years of clinical research experience in medical devices, pharmaceuticals, CROs or healthcare (Class III device experience preferred).
• Strong knowledge of GCP, ICH guidelines and FDA regulations; certifications such as RAPS or CCRP are a plus.
• Experience conducting site monitoring visits and managing study documentation, preferably on multi‑site international studies.

Required skills

• Proficiency with Microsoft Office applications.
• Experience with Clinical Trial Management Systems (CTMS).
• Familiarity with electronic trial master file (eTMF) systems.
• Experience using electronic data capture (EDC) systems.