Clinical Research Associate Job Opportunities – CBCC Global
CBCC Global Research is looking for Clinical Research Associate (CRA) / Sr. CRA
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
Work Experience: 4-8 Years Monitoring experience mandatory
Application Process
Please apply at [email protected]. Job Code : CBCC/IND/CRA (Please mentioned job code in subject line of your application )
Important Note : Freshers are not eligible for this opening, those who are having relevant experience as mentioned above can apply for this opening
