Clinical Research Associate EXCLUSIEF (pharma & devices) – home / officebased
Our clients clinical activities are growing! Therefore we are currently seeking a (home or office-based) Clinical Research Associate to join their Clinical Country Operations team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.
As a CRA, you will have the opportunity to work with innovative therapeutic fields and with challenging studies ranging from phase I – III. In some cases also within devices. We are looking for proactive, positive and self-motivated individuals to join our supportive and dynamic team. If you want to be a vibrant part of our growing team in Europe, please review this opening:
Responsibilities of the Clinical Research Associate:
- Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol;
- Communication with the medical site staff including coordinators, clinical research physicians and their site staff;
- Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
- Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements;
- Verification that the investigator is enrolling only eligible subjects;
- Regulatory document review;
- Medical device and/or investigational product/drug accountability and inventory;
- Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
- Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement;
- Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
Qualifications for the Clinical Research Associate
Minimum of a bachelor’s degree; Health or life science related field preferred;
- A minimum of 1.5 work experience as a CRA;
- Willing to travel approximately 60-80% nationally;
- Familiarity with Microsoft® Office;
- Fluent Dutch and English language skills and;
- Strong communication and presentation skills.
- A very competitive benefit package!
More information about the Clinical Research Associate? Contact Leonie Koomen at Leonie@heraklespharma.nl or 06-1051 83 23