Clinical Research Associate @ Lonza B10

Job Title: Clinical Research Associate
Job Description:

• The CRA is expected to follow the policies, procedures, guidelines, and standards for excellence and professionalism established by LONZA.
• Additionally, this position will assure that all clinical and laboratory research activity adheres to policies, procedures and requirements.
• Preparation of Informed Consent Form (ICF), Case Report Form (CRF)
• Maintain ongoing communications with sites to provide information, queries resolutions,
• Follow and track clinical research milestones for assigned projects.
• Assist QA in preparation and review of the Clinical operation SOPs and their associated documents.
• Performs other study related tasks as assigned by managers.
• Training of the personal on site for tissue collection.
• Maintain audit, SOP and training compliance.

Eligibility: M.Sc in Biotechnology/ Life science
Experience: 2-3 Years
Desired Skills:

• Thorough understanding and experience in the complete gamut of activities in clinical operations, including ICH-GCP and various regulatory requirements
• Clear and thorough understanding of discovery processes, regulatory requirements and IP management.
• Excellent written and verbal communication skills, capable of interfacing with all levels in the company.
• Pleasing personality, assertive profile with good inter-personal skills and hands on approach, Proactive, organized and flexible

Location: Hyderabad

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