Clinical Research Associate - Slovakia
Working with a full-service clinical contract research organization (CRO), providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries with the mission to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach.
As a CRA, you will specifically be responsible for the following:
- 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 review and 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 only eligible subjects are enrolled;
- Review of regulatory documents;
- Investigational product/drug and/or Medical device accountability and inventory;
- Verification and review of adverse events, serious adverse events, concomitant medications and corresponding medical condition to confirm accurate data reporting in accordance with the protocol, ICH GCP and Local Regulations;
- 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, but is not limited to providing summaries of the site?s status, significant findings, deviations, deficiencies, and recommended actions to secure compliance.
- Minimum of a bachelor?s degree, preferably in Health or life science related;
- Proven CRA experience with stable career progression;
- Fluent English & Slovak;
- Willing to travel approximately 60% within Slovakia;
- Familiarity with Microsoft® Office;
- Strong communication and presentation skills.Job location: home-based.
- Agency: Achieva Group Limited
- Reference: LC-25
Website: Achieva Group Limited
- Posted: 16th January 2023
- Expires: 13th February 2023