Clinical Development Services Agency (CDSA) has therefore been formed as a not-for-profit society to provide supportive and focused environment to host world class clinical translation through a collaborative network of clinical investigators and premier research institutions.  It will tend enterprises, particularly SMEs involved in new technology innovation, to facilitate translation of scientific know-how into viable products for public health diseases like malaria, tuberculosis and dengue among others.

Post : Clinical Research Associate

Emoluments/ Duration : up to Rs. 35,000 per month, consolidated for 12 months

Location : Clinical Study Sites in Delhi/NCR

Job profile
• Conducts clinical monitoring through site visits (site assessment, preparedness, initiation, monitoring and close out visits)
• Conducts pre-study site visits, collects and reviews data, and prepares evaluation reports; participates in the final selection of investigators and study sites
• Conducts site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with SOPs, guidelines and policies
• Monitoring the clinical study and review on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, investigational product reconciliation and disposition, review of completeness and accuracy of IP accountability files, and retrieval of relevant documents, and provides remedial training and/or initiates corrective action as required
• Imparting training to site personnel for study conduct; participates and/or conducts site meetings and prepares reports
• Ensures appropriate transmission of CRF data to the data management unit; reviews case report form queries /problems, and clarifies and/or obtains changes to data as appropriate
• Prepares site visit reports, finalize with Quality Manager’s inputs and share with the relevant stakeholders for necessary corrective and preventive action
• Conducts site termination visit, in case required and submits a detailed report to the sponsor/ site
• Assists with the development and implementation of study-specific monitoring and reporting procedures, methods, guidelines, and tools
• Setting up the study files as per the documentation practices agreed upon for the project and ensure compliance throughout study duration.
• Archiving study documents and study material as per plan.
• Escalate quality issues to Quality Manager
• Work with Clinical Portfolio Management and other internal departments on their requirements as and when required

Qualifications and Experience
Bachelor’s degree in Lifesciences with Master’s /PG diploma in Lifesciences/clinical research or equivalent 3-4 years of relevant clinical trial and/or field monitoring experience with a recognized institute / organization (CRO, pharmaceutical, biotechnology company)

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