ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success.
Post : Clinical Research Associate
Job Description
• Performing monitoring visits according to plan, document actions and follow up on action plans
• Site feasibility visits incl. analysis of site logistics, site personnel performance/quality indicators and accountability for patient recruitment strategies
• Train and guide site staff in the protocol and trial procedures to minimize protocol deviations (PDs)
• Train site staff in safety information handling and systems
• Know and meet all local and company requirements with respect to safety reporting
• Proactive use of EDC and other data source systems for preparation and conduct of site visits as well as source data verification in collaboration with data management/logistics team
• Identify potential risks and proactively take action to prevent or mitigate
• Collaborate with Data Management/logistics in resolving queries
• Ensure data cleaning cycle timelines are met in accordance with the Data Flow Plan
• Manage trial product requirements, incl. temperature deviations and training of site staff
• Motivate and build strong relations with site personnel to ensure NN is their preferred clinical research partner
• Ensure collaboration with and deliverables from vendors locally, if applicable
• Collection and management of essential documents
Candidate Profile
• Primary point of contact between site staff and NN. Acts as ambassador for the company and contributes to making NN the preferred partner.
• Responsible for taking leadership of site management for the selection and initiation of sites as well as conduct and closing activities of the appointed studies in compliance with local regulations, ICH-GCP,
• NN procedures and protocol requirements to ensure data quality and study subject protection.
• Responsible for managing the site to meet patient recruitment rate and target.
• Delivers results that have direct impact on the successful completion of the clinical program.
• Coordinates with PM and communicates to them progress and critical issues that may impair trial progress.
Additional Information
Location : India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Clinical Monitoring
End Date : 30th January, 2024
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