| Designation | Clinical Research Associate |
| Job Description | Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites for GCP compliance according to PharmaNet SOPs and/or client guidelines
Recruit investigators for participation in clinical trials
Negotiate study budgets with investigators
Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites
Review draft protocols for completeness and feasibility
Develop Case Report Forms for clinical trials
Present (e.g. study specific guidelines and procedures, case report forms, and monitoring conventions) at Investigators Meetings
Prepare and process Serious Adverse Event (SAE) reports
Prepare project management reports for clients, project personnel, and PharmaNet management
Review and verify CRFs and other clinical data, in-house, for completeness and accuracy; generate queries
Resolve queries of CRF data with study site personnel
Review Tables and Listings generated from study data
Assist in writing Clinical Study Reports
Train junior CRAs on monitoring, internal procedures, and query resolution
When allocated by study management, submit essential/required documents to a central IRB or a countrys central Ethics Committee, and, if necessary based on local requirements, the Competent Authority
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| Desired Profile | 3- 5 years of experience in Clinical Monitoring
Holding experience in Consumer studies is desirable
BS, B.Pharm, Masters Degree in life sciences/ clinical research
Good Communication skills
Home based opportunity |
| Experience | 3 - 5 Years |
| Industry Type | Medical, Healthcare, Hospitals |
| Role | Clinical Research Associate/ Scientist |
| Functional Area | Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology |
| Education | UG - Any Graduate - Any Specialization
PG - Any PG Course - Any Specialization, Post Graduation Not Required |
| Location | Gurgaon |
| Keywords | Clinical Research Associate, Clinical Research, Monitoring |
| Contact | HR
inVentiv International Pharma Services Pvt Ltd
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| Job Posted | 30 Sep |
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