Job description
Role
Summary
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.
Quality Responsibility
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.
Qualifications :
Skill Requirements
Desired
ProfileBiological background (Masters) or equivalent
2-3 years experience in clinical research.
Demonstrates high level of Customer Relationship
Management.
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
Summary
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.
Quality Responsibility
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.
Qualifications :
Skill Requirements
Desired
ProfileBiological background (Masters) or equivalent
2-3 years experience in clinical research.
Demonstrates high level of Customer Relationship
Management.
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
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