Working directly with sponsor
Home based role
Work with a close knit team
Supportive management focused on career development and progression
About the company
This company is an innovative, medium-sized global CRO currently based in over 50 countries. They are well known for their great working culture and dynamic team providing full and functional clinical research solutions to biotech, pharmaceutical and medical device industries.
About the opportunity
The CRA/SCRA is responsible for the preparation, initiation, monitoring and closure of allocated sites. You work in close collaboration with other Monitors and the Local Study Delivery Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner
Actively participate in local Study Delivery Team meetings.
Drive performance at the sites. Proactively identify study-related issues and escalates as appropriate.
Ensure timely delivery of proper applications/documents for submission to Regulatory Authorities.
Track and manage agreed payments at study site level.
Participate in training and mentoring of new members of the local clinical team ensuring compliance with ICH/GCP
Ensure that all study documents are ready for final archiving and sign-off completion of local part of the Trial Master File.
Contribute to process improvements, knowledge transfer and best practice sharing.
Skills and Experience
Tertiary degree (life science preferred)
Minimum of 18 months independent local clinical monitoring experience
Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
Thorough knowledge of monitoring procedures
Good understanding of the clinical trial process
Able to work in fast paced environment
Good communication, interpersonal, analytical and negotiation skills
Well known for their culture and low turnover, this company provides a close knit and supportive team environment.
How to Apply
Click apply or contact Christine Bristol, Executive Consultant on +61 2 8877 8766 for a confidential discussion.
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About the Company Our client is a full-service clinical contract research organisation (CRO), who cover phases I-IV across biotechnology, pharmaceutical and medical device industries. This company covers all major therapeutic areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.
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About the CompanyOur client is a full-service clinical contract research organisation (CRO), who cover phases I-IV across biotechnology, pharmaceutical and medical device industries. This company works within all major therapeutic areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. This company...