Clinical Research Associate/Sr. Clinical Research Associate

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.