Clinical Research Associate- Pune

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 mandatoryPatient base PK studies monitoring experience is preferred

Key Responsibilities
Overall site management of clinical trials and Patient base PK studiesEnsure effective communication to sitesPrepare for site visitsAssist PM in developing the project planPrepare the Site Activation checklistHandle back-office monitoring/centralized monitoringCoordinate with sites for resolving DCFsOther 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 studiesUnderstanding of the ethics committee and informed consent form requirementsAwareness about AE/SAE/deviations in submission and documentation requirementsAwareness about phase trials, BA/BE studies and trial-related setups, instruments, staff and other site requirementsAwareness about site selection requirements, aspects of (onsite/remote) monitoring, and knowledge about indication-specific good sites pan-India and handling site issuesAwareness on issues during patient recruitments and the ability to effectively overcome those issuesAwareness about the EDC platforms, IP handling requirement and its importance

Please apply at career@cbcc.global.

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