QUINTEN’s expertise in strategic data development with integrated evolving R&D capabilities and advanced analytics combined with ECLEVAR’s medical device clinical trials insights, solutions and execution capabilities have enabled us to create Eclevar Medtech and become one of the world’s most innovative Medical Device CROs and trusted compliance partner.

ECLEVAR MedTech is a medical device contract research organization (CRO) specializing in regulatory compliance and real world evidence post-market solutions. ECLEVAR MedTech’s global team is focused on advancing and accelerating the development of medical devices by utilizing the potential of artificial intelligence (AI) technologies including the monitoring and synthesis of scientific literature to create Clinical Evaluation Reports (CERs) and generating real world data necessary for Post-Market Clinical Follow-up (PMCF) reports.

Driven by its innovative data science and machine learning capabilities, ECLEVAR MedTech provides medical device manufacturers with cost-effective solutions to comply with Medical Device Regulations (MDR) to bring safer medical devices to patients.

Our goal is to advance and accelerate how medical devices are developed by analysing and interpreting clinical data in a way that it is easily understandable, exploits the full potential of the data and advances healthcare globally.

ECLEVAR MedTech’s headquarter is in Paris, France. Expansions are planned to operate throughout Europe and the United States.
For this expansion, we are looking for talents to join us.

**Your Responsibilities

A Clinical Research Associate (CRA) is responsible for conducting monitoring activities at a clinical site(s) for a clinical trial(s). The CRA may be responsible for multiple projects and must be able to work both independently and in a team environment.

As a CRA you will have to anticipate, recognize, and resolve challenges in the assigned study site.

• Review and/or input to study protocol, CRF and validation tools.

• Preparation and/or review of any kind of study documents, monitoring guidelines, CRF completion guidelines, patient information and informed consent forms etc.

• Prepare the submission to the Independent Ethics Committees (central and local) and when applicable to Competent/Regulatory Authorities.

• Assists in developing of Investigator and Institution contracts and budget templates, negotiates budgets with sites and arranges site payments.

• Participates in Investigators’ selection/feasibility: for example: phone contacts, questionnaire in the appropriate country.

• Conduct of site qualification visits (pre-study visits).

• Conduct of site initiation- and site close out visits.

• Conduct of regular monitoring visits.

• Ensures that the site is equipped with all necessary supplies for timely reporting and that the procedures (sampling storage and shipment logistics) are appropriately adhered to.

• Writes a corresponding site visit follow-up letter and documentation for the purpose of on-site quality optimization.

• Distributes any documents collected during the monitoring visit to the appropriate department (data entry, assistants for archiving etc.).

• Responsible for the quality of data from his/her own sites.

• Resolves questions/issues with investigator/trial staff including query verification.

• Resolves and writes Data Clarification Forms and reviews data-listings.

• Manages his/her own visit schedule, appointments and the following-up of issues between visits under, along with regular communication with the sites and the clinical study team.

• Maintain close contact with the investigators on-site, the center study coordinator, the pharmacist, and other involved parties to be aware of any possible patient enrolments, the enrolled patients’ status, the IP stock and any further site requests or problems.

• Filing and update of study documentation in the Investigator Site File and Pharmacy File (if applicable) and the TMF or Project File within the clinical office throughout the study.

• Review of Trial Master File (TMF) and ensure that all documents are in order, logical, accurate, complete, up-to-date, and ready for a study audit and/or inspection.

• You must be fluent in French and English.

• You have undergraduate degree or its international equivalent in clinical, science, or health-related field

• You have at least 2 years’ experience in clinical trials and clinical monitoring

• You know very well the ICH / GCP regulations.

• You have working knowledge of EU Directives / MDR regulations /GDPR. Also ISO14155 regulations, medical device development, and clinical monitoring procedures.

• You are well know for your organizational and time-management skills, able to meet deadlines

• You are customer service focused and maintains a positive, results orientated work environment

1. Phone meeting with the HR
2. Meeting in our office in Paris with the CEO of Eclevar