Senior Clinical Research Associate

🕒 September 14

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Establishment Labs

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2012

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

Healthcare • Consulting • Food & Beverage

Establishment Labs is a global medical technology company committed to advancing women's health and wellness through innovative Femtech solutions. Specializing in breast health, aesthetics, and reconstruction, the company offers groundbreaking products like Motiva SmoothSilk breast implants and the Motiva Flora tissue expander. Their technologies are underpinned by scientific research and supported by an extensive portfolio of over 200 patent applications and numerous publications. Establishment Labs aims to normalize and democratize breast health through science-based innovations and evidence-based safety, striving to make a positive social, environmental, and economic impact with their solutions.

📋 Description

• Coordinate and oversee clinical trial activities from study start-up through closeout • Conduct remote and on-site monitoring visits, including qualification, initiation, routine monitoring, and closeout visits • Ensure protocol compliance, data accuracy, source document verification, and overall study quality • Maintain study documentation, TMF/eTMF files, and inspection-ready records • Support safety reporting activities, including adverse events, serious adverse events, and follow-up actions • Collaborate with investigative sites, CROs, vendors, and internal stakeholders to ensure successful study execution • Assist with regulatory submissions, FDA reporting, ClinicalTrials.gov updates, and post-market clinical activities • Support audits, inspections, and quality initiatives while ensuring ongoing regulatory compliance • Contribute to process improvements, SOP development, and clinical operations best practices

🎯 Requirements

• Bachelor’s degree in Life Sciences, Health Sciences, Nursing, Pharmacy, or a related field • 4+ years of clinical research experience within the medical device, pharmaceutical, CRO, or healthcare industry • Strong knowledge of GCP, ICH guidelines, FDA regulations, and clinical trial processes • Experience conducting site monitoring visits, source data verification, and managing study documentation • Proficiency with Microsoft Office applications • Strong organizational, problem-solving, and communication skills • Ability to manage multiple priorities independently • Ability and willingness to travel domestically and internationally as needed • Class III medical device experience preferred • Master’s degree preferred • RAPS, CCRP, or similar certification preferred • Multi-site and international study experience preferred • Experience with CTMS, eTMF, and EDC systems preferred • Audit and inspection support experience preferred

🏖️ Benefits

• Equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status • Remote work arrangement • Opportunity to join an innovative international company in hyper-growth • Opportunity to contribute to a more equal opportunity workplace