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Clinical Research Associate Jobs in Gurgaon - Takeda

Clinical Research Associate

Takeda
experience-icon 0 to 3 Years
salary-icon Not disclosed
qualification-icon Any Graduate, Other Course
Expired

Posted: 13 Mar 21

Job Description

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

Job Particulars

Education Any Graduate, Other Course
Who can apply Freshers and Experienced (0 to 3 Years )
Hiring Process Face to Face Interview
Employment Type0
Job Id1145362
Job Category Others
Locality Address
Country India

About Company

Takeda
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