Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.
Post : Inhouse Clinical Research Associate
Job Description
The Inhouse Clinical Research Associate (IHCRA) provides in-house support to the clinical team according to project requirements, ICH GCP guidelines, local or global regulatory requirements and Novotech or Client SOPs
Responsibilities
• Co-ordinate and maintain clinical study documentation in the Trial Master Files (TMF) including the tracking of documents, preparation for internal/external audits, conducting routine QC reviews and final reconciliation, according to the requirements of ICH GCP and Novotech (or client) SOPs.
• Support the clinical team in essential document development, collection and management process including any translations according to Good Documentation Practice, ICH GCP and Novotech (or client) SOPs.
• Manage the Clinical Trial Management System (CTMS), ensuring site compliance scores are maintained to a high level and entered in accordance with company requirements. Follow up with relevant team to update and maintain site milestones, subject tracking and PISCF’s, ensuring accuracy and completeness of the data.
• Create the Investigator Site Files, coordinating the ordering, dispatch and tracking of trial materials (e.g., patient cards and diaries, lab supplies, drug supplies, etc.) according to the logistical requirements of the study. Ensure safe and orderly storage of study materials at Novotech and maintain stock reports as requested by the PM/CRA.
Candidate Profile
• Relevant experience/qualifications in Life Sciences or related field or administration would be preferable. Experience working in the pharmaceutical, CRO or healthcare industry is advantageous.
• 1-2 years’ experience as inhouse CRA or relevant roles.
Additional Information
Experience : 1-2 years
Qualification : Qualifications in Life Sciences or related field
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 10th May 2024
See All B.Pharm Alerts M.Pharm Alerts M.Sc Alerts Lucknow Alerts
See All Other Jobs in our Database
.png)
