CRA II/III- BUDAPEST
- Experience Level
- Experienced (non-manager)
Upsilon Global are working with an award winning mid-size global CRO that is present in over 35 locations globally and work in a number of therapeutic areas like oncology, CNS, cardiology, metabolic diseases and anti-infective in all phases.
They are seeking a Clinical Research Associate to join their team in Budapest in the clinical operations team.
The CRO offers great continuous career development and training and has been named one of the top work place by their employees globally.
• Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
• Communication with the medical site staff including coordinators, clinical research physicians, and their site staff;
• Verify 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;
• Assess the clinical research site’s patient recruitment and retention success and offering suggestions for improvement; and
• Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
• Must have a minimum of a bachelor’s degree in a health or science related field;
• Must maintain a valid driver’s license and the ability to drive to monitoring sites;
• Proficient knowledge of Microsoft® Office;
• Strong communication and presentation skills; and
• Must be detail-oriented and efficient in time management.