Clinical Research Associate Jobs in Gurgaon - Takeda
Clinical Research Associate
Takeda
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
Technical - Good working knowledge of GCP and local clinical trial rules and regulations
Analytical skills- Attention to detail, Good communication skills
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
Technical - Good working knowledge of GCP and local clinical trial rules and regulations
Analytical skills- Attention to detail, Good communication skills
Job Particulars
Role research jrf srf
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
State Haryana
Country India
About Company
Takeda
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