Sr. Clinical Research Associate (Remote - USA)

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

About Us:

Establishment Labs is changing the medical device, breast health, aesthetics and reconstruction industry by designing, developing, and manufacturing an innovative portfolio of advanced medical aesthetic device technologies and wellness solutions. It is currently the world’s fastest-growing women’s health company.

Our Femtech solutions are proudly produced at two MDSAP-certified, carbon neutral, LEED Gold certified, state-of-the-art manufacturing facilities in Costa Rica and are approved for sale in more than 85 countries.

Since 2018 the company trades on the NASDAQ stock exchange under the ticker symbol ESTA and has a market cap of around $1.8 billion.

This is an exciting opportunity to join an innovative international company in hyper-growth as we launch a significant revolution to transform the women´s aesthetics industry.

Please note this is a remote role, we will be considering roles from around the United States.

Objective

The Senior Clinical Research Associate is responsible for managing and monitoring clinical studies from start-up through closeout, ensuring compliance with study protocols, GCP, ICH guidelines, FDA regulations, and applicable global requirements. This role partners with sites, CROs, and cross-functional teams to support patient safety, data quality, regulatory compliance, and successful study execution.

Responsibilities

• 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 (AEs), serious adverse events (SAEs), 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 (Master’s degree preferred).
• 4+ years of clinical research experience within the medical device, pharmaceutical, CRO, or healthcare industry (Class III medical device experience preferred).
• Strong knowledge of GCP, ICH guidelines, FDA regulations, and clinical trial processes (RAPS, CCRP, or similar certification preferred).
• Experience conducting site monitoring visits, source data verification, and managing study documentation (multi-site and international study experience preferred).
• Proficiency with Microsoft Office applications (experience with CTMS, eTMF, and EDC systems preferred).
• Strong organizational, problem-solving, and communication skills with the ability to manage multiple priorities independently (audit and inspection support experience preferred).
• Ability and willingness to travel domestically and internationally as needed

Important Note: This job description includes the necessary aspects required to evaluate this job position. It should not be used as a comprehensive list of all responsibilities, skills or functions. At Establishment Labs we’re committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability (visible and not visible), gender, gender identity or expression, or veteran status. We strive to be a more equal opportunity workplace.