Clinical Research Associate

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. 

Objective

The Clinical Research Associate (CRA) is responsible for overseeing all aspects of the study lifecycle, including study design, implementation, site qualification, site initiation, and ongoing monitoring. This role ensures that clinical investigations and Post Market Clinical follow up studies in the United States and internationally are conducted in full compliance with regulatory and quality requirements. 

Main Responsibilities

• Prepare documents required for IRB’s/Ethical Committees submission. This includes developing and writing clinical trial protocols, design Case Report Forms, Patient and Investigator Brochure, Informed Consent Form, etc.
• Assist and review interim and annual study reports and response for FDA.
• Communicate with Investigative Sites and consultants on conducting clinical trials.
• Data compilation, ensuring quality control and compliance with protocol and provide initial analysis of results.
• Monitor clinical trial progress through a combination of data review and on-site monitoring visits.
• Conduct site visits for pre-qualification, qualification, initiation, monitoring and close-out.
• Verify that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification, collection of completed CRF forms.
• Discuss study results with a biostatistician for clinical trial reports. Archive study documentation and correspondence and prepare final reports.
• Provide clinical support to Quality Affairs in the analysis of clinical complaints and Failure Mode and Effect Analysis (FMEA).
• Provide clinical support to Regulatory Affairs in the creation of documents required for products registration and technical file (Clinical Evaluation Report).
• Create, implement, and administer methods and procedures to enhance operations, as appropriate.
• Stay up to date on ethical considerations, scientific principles, legislation and regulatory guidelines and requirements related to Clinical Evaluation Report and Clinical Trials. (ISO, MEDDEV, MDR, etc).
• Perform miscellaneous job-related duties as assigned

Technical Requirements:

• Bachelor’s degree in health, life science, or other relevant field of study.
• Advanced English C1 scored
• 2+ years of experience on similar roles
• Knowledge of GCP/ICH guidelines
• Microsoft Office suite (Word, Excel, PowerPoint, Planner, etc.)

This role requires periodic travel to the United States and other regions. A valid U.S. visa and full travel availability are essential.

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.