Takeda jobs - Clinical Research Associate

Clinical Research Associate (CRA) – 

Role And Responsibilities

CRA will be responsible for managing clinical study related activities and documentation of studies conducted in India, reporting to Clinical Operations Manager.

Position Responsibilities

• To successfully conduct the sites visits – Site Selection, Site Initiation, Interim Monitoring, Site Close Out
• Perform site monitoring visits to include review of source document, CRF, ICD, Patient Diary, Site TMF, other documents as applicable
• Monitor study process to ensure compliance with protocol requirements, applicable regulatory regulations, GCP and internal processes
• Monitor and track patient enrollment and study progress
• Ensure timely, accurate and complete collection and submission of study data
• Maintain TMF and other internal documentation as per applicable internal processes
• Prepare the site for possible regulatory inspection/ internal audits
• Ensure 100% adherence to the monitoring and study plan
• Follow up on outstanding issues at the sites & assist sites to get them closed
• Support the clinical quality in managing CAPA’s and other study audit observations
• Support the clinical operations manager in performing study/CRO oversight activities at study completion
• Ensure collection of all data and remaining study supplies for return
• Ensure that appropriate study documents are complete and properly filed
• Archival with inventory list of source documents/ CRFs/ CTM/ Other at site and internally
  
  

Profile Life Sciences Graduate/Postgraduate with 3-5 years’ experience in clinical trial industry as Clinical Research Associate.

Technical - Good working knowledge of GCP and local clinical trial rules and regulations

Analytical skills- Attention to detail, Good communication skills