Clinical Research Associate (CRA)
Company: Mason Alexander Agency
- Location: Netherlands
- Seniority: Senior
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
A Medical Device company with headquarters in Dublin, Ireland are seeking a full time Clinical Research Associate (CRA) to join their team to support pivotal trials of a novel cardiovascular active implantable device. It’s an exciting connected product which also consists of an external device and web based application for monitoring of the patients cardiovascular activity.
The CRA will oversee site management and training for sites based in The Netherlands, maintain study related documents, and perform study monitoring to ensure that sites conduct clinical studies as required, the study protocol, and applicable regulations and guidelines.
This role can be based in Dublin or The Netherlands.
Responsibilities:
- Conduct site monitoring visits, including selection, initiation, monitoring and close-out, in accordance with study procedures and regulatory requirements (i.e., Good Clinical Practice, GCP) in the Netherlands and potentially in other EU Geographies if needed. Document findings and action plans accordingly.
- Facilitate the execution of the Company’s clinical portfolio, including ongoing and new interventional studies, in compliance with international standards.
- Evaluate the quality and integrity of study site conduct to ensure alignment with protocols requirements.
- Proactively identify and implement improvements to enhance overall clinical trial performance
- Build and maintain professional relationships with key physicians, clinical investigators, and consultants to ensure efficient and timely clinical study execution.
- Support sites in tracking and driving subject recruitment
- Ensure accurate documentation of site materials to support the Trial Master File (TMF), verify that the investigator files comply GCP and local regulatory requirements.
- Train and educate medical personnel to specific procedures and equipment.
- Collaborate with internal departments to develop product-specific training materials for clinical trial teams.
- Provide technical support and troubleshooting to clinical trial.
- Travel up to 40% to support on-site activities as required.
- Apply influencing and consulting skills to guide clinical practices.
- Coordinate with Contract Research Organisations (CROs) and independent contractors to execute the clinical portfolio as needed.
- Manage and track study-related activities in-house and onsite to identify and mitigate potential issues efficiently.
- Engage with the Quality Management System (QMS) to support the overall quality strategy & support the achievement of the business quality objectives.
Experience Requirements:
- Bachelor’s degree or higher in an engineering or health care related field.
- 3+ years' experience from similar positions in medical device/pharma industry.
- Fluent in English and Dutch is required
- Strong understanding of implantable devices, medical imaging, cardiovascular anatomy and physiology, and heart failure.
- Self-motivated, proactive, independent.
- Strong stakeholder engagement skills.
