Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Products and services span its customers’ needs from research to final product manufacture. It is the global leader in the production and support of chemical and biological active pharmaceutical ingredients. Lonza is also the world leader in microbial control providing innovative, chemistry-based and related solutions to destroy or to selectively inhibit the growth of harmful microorganisms. In addition, Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. Furthermore, the company is a leading provider of value chemical and biotech ingredients to the nutrition and agro markets.
Post: Clinical Research Associate-000004FB
Job Description
Tissue sourcing:
- 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.
Lab activities:
- To work with team of Research Associates in developing products in cell biology, mammalian cell transfection products and develop cell/biochemical based assays
- Execution of/managing projects within the time lines with high quality reproducible results.
- Is knowledgeable and complies with all pertinent safety policies, rules and regulations.
- Ensure that all team members comply with safety rules and regulations.
Candidate Profile
Skill Requirements:
- Biological background (Masters) or equivalent
- 3-4 years’ experience in clinical research and working in labs in the areas of cell/molecular biology
- Skilled and experienced in writing SOPs/reports.
- Demonstrates high level of Customer Relationship
Desired Profile
- 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
Additional Information:
Location: Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: R&D
End Date: 18th December, 2014
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