Clinical Research Associate

4 days ago

Ahmedabad, India CBCC Global Research Full time

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

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