R&D Job @ Cipla | Work as Senior Clinical Research Associate

Cipla is one of the most respected pharmaceutical companies not just in India but across more than 170 countries. Our portfolio includes 2000 products in 65 therapeutic categories with one quality standard globally.

Job Title : Senior Clinical Research Associate.

Experience : 4 – 8 Years

Location : Mumbai

Qualification : M. Pharm or MSc in any subject or Clinical Research. MSc in Clinical Research is preferable.

Job Description

• Review of clinical trial master documents (IB, Protocol, PIS, ICF, Subject diary, CRF and questionnaire) and provide inputs.
• Review translation and back translation of the PIS, ICF, Subject Diary and Questionnaire and provide inputs.
• Coordinate with Legal and Sites for CDAs and CTAs as delegated
• Coordinate with investigators team and clinical trial assistant for Ethics committee and DCGI submission of clinical trial documents.
• Assist in resolution of queries raise by DCGI/EC
• Conduct Site Identification and evaluation based on trial requirements.
• Overlook logistics of clinical trial material and samples
• Perform timely initiation of clinical trials as per project plan
• Monitor delegated ongoing clinical trials
• Offsite monitoring through electronic data capture of complex Multi-Centre project
• Verify data entered in CRF is consistent with source data (Source data verification and review)
• Collect completed CRF in case of Paper based CRFs
• Ensuring timely transfer of paper CRF or subject diary pages to DM vendor & coordinate in query resolution
• Closing study sites on completion of the trial
• Ensuring accountability of Clinical trial material and drugs at the trial sites handled
• Timely request concerned team member for creating drug requisition, randomization plan, insurance and trial registration
• Overlook registration and regular updating of trials on clinical trial registry of India
• Assist Clinical trial administrator for investigator and CRO payments
• Coordinate with CROs, Central labs and translational agencies on delegated projects
• Provide resolution to compliance issues and take necessary corrective actions if required
• Review and provide inputs on Clinical study report (CSR)
• Creation and review of Standard Operating Procedures of CTG
• Coordinate with the Vendors for requesting study proposal and update to the reporting manager

• Background in science and/or other relevant discipline and appropriate experience.
• Knowledge of GCP guidelines and relevant regulations for the conduct of clinical trials.
• Ability to review and evaluate clinical data.
• Good communication and interpersonal skills.
• Good understanding of drug development and clinical trial process.
• Good planning and organizational skills.
• Competent computer skills.
• Ability and willingness to travel at least 50% of the time (domestic).

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