Job description
We believe the dedicated people who work at CBCC are the best. They each have deep compassion and a single focus on the well-being of our patients. If you would like to join our devoted team, the following positions are open.
Work Experience:
4-8 Years
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
Work Experience:
4-8 Years
Ahmedabad, Mumbai, Bangalore, Hyderabad , Pune or DelhiPre-Requisite Skills:
Onsite monitoring experience mandatory