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-000003HP
Job Description
This position will work closely with tissue acquisition group, cell biology group, external collaborators, hospitals, pathology physician assistants, operating room personnel, and other physicians, scientists and logistic personal.
Primary Role Responsibilities
1.· 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.
2. Assist QA in preparation and review of the Clinical operation SOPs and their associated documents.
3. Performs other study related tasks as assigned by managers.
4. Training of the personal on site for tissue collection.
5. Maintain audit, SOP and training compliance.
Candidate Profile
Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.
Safety Responsibility
· Is knowledgeable and complies with all pertinent safety policies, rules and regulations.
· Ensure that all team members comply with safety rules and regulations.
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Skill Requirements
Biological background (Masters) or equivalent
2-3 years experience in clinical research. Demonstrates high level of Customer Relationship Management.
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: 10th May, 2014
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