(Job code: CBCCIND/CO/CRA)
Work Experience: 4-8 Years
Work Location: Ahmedabad, Mumbai, Bangalore, Hyderabad , Pune or Delhi
Pre-Requisite Skills: onsite monitoring experience mandatory
Job Requirements:
Key Responsibilities
Overall site management of clinical trials
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
We will notify you if you fit in
