We are currently recruiting for a Senior Clinical Research Associate in Austria for our Flexible Solutions team. You ideally be located in Wien/Salzburg, Austria, as a home based employee. As an experienced CRA you’ll be involved in initiation, routine & close out visits concentrating on sites in Austria. Successful candidates will enjoy the benefits of working for a company that values a WORK / LIFE BALANCE.
- Ability to monitor Clinical study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines - Excellent understanding of Serious Adverse Event reporting - Previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits) in Austria.
- Fluency in speaking and writing both English and German
- Oncology experience USPs of CRA role: - Unlike some CRA roles you will not be pushed to satisfy unrealistic ‘monthly visit’ targets
- Join a stable team of CRAs across Austria and benefit from outstanding training and development, both initially and throughout your career
- Join a company where people tend to stay for 6-10 years rather than 1-3!
- Join a genuinely friendly and supportive company where they allow individuals to take ownership of their own performance.
• Acts a primary site contact and site manager for all operational and routine protocol issues in support of clinical research studies.
• Communications with sites on issues related to protocol conduct, enrolment/retention, protocol deviations, regulatory documentation, site audits/inspections, overall site performance, and financial payments.
• Performs on site- monitoring visits, esuring site compliance with protocol, ICH, GCP, Merck global standards, local laws and regulations, including but not limited to review of informed consent, AE/SARs, Health Authority documention, and IMP supplies. Performs source document verification of subject data and query resolutions.
• Functional expert on the CRA role and would be expected to role model and mentor junior level CRAs. Share best practises and make recommendations for continuous quality improvement. Actively participate in change management processes. Represent the department on cross functional/interdepartmental teams and take on extra assignments as they arise.
• Manage at least a full complement of sites with multiple protocols depending on study/site complexity. Provide input to Site Selection utilizing site evaluation and validation processes.
• Maintains accurate study site information in the CTMS and records visit and non-visits contracts appropriately and in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out. Experience: Minimum Required: at least 8-12 years experience in clinical monitoring, oncology experience
• In lieu of the above requirements, candidates with > four (4) years supervisory experience in a health care setting and three (3) years clinical research experience in the pharmaceutical or CRO industries (including monitoring) may be considered • Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
Key words: Clinical Research, CRA, SCRA, Clinical Research Associate, GCP, Monitor, Monitoring, Senior Clinical Research Associate, CRA I, CRA II, CRA III, LCRA, Oncology, Cardiovascular, Neuroscience, Immunology, Infectious Diseases, Metabolism, Field Based, Home Based, CRO, Pharmaceutical, Vienna, Austria.
• Advanced site monitoring skills
• Advanced study site management skills
• Advanced registry administration skills
• Ability to work with minimal supervision
• Good planning and organization skills
• Good computer skills with good working knowledge of a range of computer packages
• Advanced verbal and written communication skills
• Ability to train and supervise junior staff
• Ability to resolve project-related problems and prioritizes workload for self and team
• Ability to work within a project team
• Works efficiently and effectively in a matrix environment Degree in life sciences OR equivalent experience in clinical monitoring Preferred: • One (1) or more year’s additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred
• Local project coordination and/or project management Other Information: These roles are full time & permanent positions employed through Covance.