Clinical Research Monitoring (CRA)

Clinical Research Associate
Our European clinical activities are growing rapidly, and we are currently seeking full-time, home-based Clinical Research Associates to join our Clinical Monitoring team, in the country of Croatia. This is a new, permanent, entity for us and so our recruitment processes may be extended and some benefits may be confirmed but not yet in place depending on candidates preferred start date.
This position will be instrumental in growing the team in Croatia and accomplishing tasks and projects that are vital to the company's success. The Clinical Research Associate at Medpace is offered the unique opportunity to be involved at every stage of the development of medical therapeutics, in different, including rare diseases, cell and gene therapy, areas. Our successful Clinical Research Associates possess varied backgrounds in the medical and related healthcare fields, including but not limited to; Registered Nurses, Dieticians, Pharmacists, Faculty of Science Graduates and Research Assistants. An extensive training program provides the platform to effectively and confidently carry out your duties, the Medpace unique way.
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;
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.
Minimum a Bachelor of science in health-related field, MD or equivalent
Minimum of 1 year independent CRA monitoring
Broad knowledge of medical terminology and clinical patient management
Basic knowledge of drug therapy techniques and clinical research methodologies
Comprehensive knowledge of Local Regulations and ICH GCP
Fluency in Croatian and English
We kindly ask to submit applications in English
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 6,000 people across 40+ countries.
The work we do today will improve the lives of people living with illness and disease in the future.
Flexible work environment
Structured career paths with opportunities for professional growth
Employee health and wellness initiatives
Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility