ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development – from compound selection to Phase I - IV clinical studies ICON enjoys a strong reputation for quality and is focused on staff development.
Post : Clinical Research Associate
The role : As a CRA II you will work on clinical trial monitoring based on your experience.
The Clinical Research Associate is the person in Trial Coordination and Site Management that serves as primary contact point between the sponsor and the investigational site.
This position is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through database lock.
Responsibilities include site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, monitoring and close-out.
Partner with the CTA/IDA, LTM and GTM to ensure overall site management while performing trial related activities for assigned protocols.
• Required a Bachelor degree with a minimum of 2 years clinical trial monitoring experience.
• Previous monitoring experience in Global trials preferred.
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
• Strong IT skills in appropriate software and company systems.
• Willingness to travel .
• Good written and oral communication skills.
Qualification : Bachelor degree
Location : Delhi, Ahmedabad, Cochin, Pune, Lucknow, Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th January, 2022
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