Covance Senior Clinical Research Associate (SCRA) in Sydney, Australia
Are you an exceptional Senior Clinical Research Associate (SCRA) based in Sydney or Melbourne, Australia that has independent trial site monitoring experience and would like to experience working at a client site while remaining an employee of Covance?
Our Flexible Solutions Clinical Research Associates manage all aspects of study site monitoring according to Client SOP, GCP, and ICH guidelines, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.
Study startup which include IRB/IEC submission, site selection, recruitment of potential investigators, notifications to regulatory authorities, translation of study-related documentation
Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned
Study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
Site management as prescribed in the project plans
Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
Independently perform Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
May support in organization of meetings and other tasks as instructed by supervisor
Covance Australia is committed to providing Clinical Research Associates; the flexibility to work from home, the freedom to grow careers across all phases and areas of clinical trial operations as well as provide technology and processes that help to manage time and workload.
Covance is one of the world’s largest and most comprehensive drug development services companies, with more than 13,000 employees in 60 countries. We began operations Asia Pacific in 1988 and today have more than 1000 employees in 14 countries across the region. Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.
At Covance, you will join like-minded collaborative professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world.
Discover your potential in a company that truly invests in you. Talk to us to learn more and explore your career. Apply online today.
University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
In lieu of the above requirement, candidates with four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered
Typically 4+ years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits).
Knowledge of the Australia/ NZ site and regulatory environment
Experience monitoring Australian study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
Excellent understanding of Serious Adverse Event (SAE) reporting
Job Number 2018-17839
Job Category Clinical Research Associate
Position Type Full-Time
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.