Clinical Research Associate- Pune

24 hours ago


Pune, Maharashtra, India CBCC Global Research Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Dear Candidate,

CBCC Global Research is looking for CRA/Sr. CRA with onco PK experience for Pune location.

Job Code : CBCC/IND/CRA (Please mentioned job code in subject line of your application )

Work Experience:

3-8 Years Monitoring experience with Oncology PK studies is mandatory

Work Location:

Pune

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

Please apply at

Important Note : Freshers are not eligible for this opening, those who are having relevant experience as mentioned above can apply for this opening .



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