job title:clinical research associate(cbcc)

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