♦ Provide clinical support for projects according to Covance Standard Operating Procedures, ICH Guidelines and GCP ♦ Develop and/or maintain tracking systems for clinical projects ♦ Assist teams and conducts site monitoring of clinical research studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP ♦ Site management responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP
We are looking for a minimum of three to six months' monitoring experience. Ideally Melbourne based.
Minimum Required: • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure) • In lieu of the above education requirement, candidates with a minimum of 6 years recent clinical monitoring experience will be considered. • Thorough knowledge of regulatory requirements • Thorough understanding of the drug development process • Fluent in local office language and in English, both written and verbal • Or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
Preferred: • Thorough knowledge of company SOPs regarding site monitoring
Minimum Required: • Two (2) years of Clinical Monitoring experience • Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs • 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 • Valid Driver's License
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 experience
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