CBCC Global Research, we are accelerating medical therapy development by providing high quality, affordable and innovative solutions. We provide strategic solutions for all phases of clinical trials through efficient delivery of services for the flawless execution of projects, on time – every time. We are committed to achieving excellence in all research projects by ensuring scientific validity, data integrity and compliance with the latest regulatory guidelines, thus striving to be a leading global clinical research organization (CRO).
Post : CRA/Sr. CRA
Job Code : CBCC/IND/CRA (Please mentioned job code in subject line of your application)
Work Experience : 4-8 Years Monitoring experience mandatory
Work Location : Ahmedabad, Mumbai, Bangalore, Hyderabad, Pune or Delhi
Pre-Requisite Skills : Minimum 2 years onsite monitoring experience mandatory Patient base PK studies monitoring experience is preferred
Key Responsibilities
• Overall site management of clinical trials and Patient base PK studies
• Ensure effective communication to sites
• Prepare for site visits
• Assist PM in developing the project plan
• Prepare the Site Activation checklist
• Handle back-office monitoring/centralized monitoring
• Coordinate with sites for resolving DCFs
• Other duties as assigned by PM, Head-PM, and DO
Technical Experience
• Awareness about current regulation guidelines (GCP, NDCT rule, COVID guidance, RECIST, USFDA/EMA guidance etc.)
• Strong therapeutic knowledge for better handling of current studies
• Understanding of the ethics committee and informed consent form requirements
• Awareness about AE/SAE/deviations in submission and documentation requirements
• Awareness about phase trials, BA/BE studies and trial-related setups, instruments, staff and other site requirements
• Awareness about site selection requirements, aspects of (onsite/remote) monitoring, and knowledge about indication-specific good sites pan-India and handling site issues
• Awareness on issues during patient recruitments and the ability to effectively overcome those issues
• Awareness about the EDC platforms, IP handling requirement and its importance
Education
UG : B.Tech/B.E., B.Pharma, B.Sc in Any Specialization
PG : MS/M.Sc(Science) in Any Specialization, M.Pharma in Any Specialization
Apply at career@cbcc.global
Important Note : Freshers are not eligible for this opening, those who are having relevant experience as mentioned above can apply for this opening.
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