inVentiv Health Clinical, a leader in drug development services, has a global infrastructure, therapeutic expertise, and commitment to quality that is unmatched in the industry. For pharmaceutical, biotechnology, generic drug, and medical device companies of all sizes around the world, inVentiv Health Clinical can help you transform promising ideas into commercial reality.
Post: Clinical Research Associate II
Job Description
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Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites for GCP compliance according to PharmaNet SOPs and/or client guidelines
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Recruit investigators for participation in clinical trials
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Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites
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Review draft protocols for completeness and feasibility
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Present (e.g. study specific guidelines and procedures, case report forms, and monitoring conventions) at Investigators’ Meetings/Site Initiation Visits
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Prepare and process Serious Adverse Event (SAE) reports
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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
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Review Tables and Listings generated from study data
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When allocated by study management, submit essential/required documents to a EC or a country’s central Ethics Committee, and, if necessary based on local requirements, the Competent Authority
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Support project managers in routine tasks.
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Prepare and maintain study files.
Candidate Profile
2-3 years of experience in Clinical Monitoring (excluding in-house experience)
1 year experience in electronic data capture desirable.
Holding experience in Consumer studies is desirable
Masters Degree in life sciences/ clinical research
Good Communication skills (verbal and written)
Additional Information:
Experience: 2-3 years
Job ID: 7439
Location: Gurgaon
Industry Type: Pharma, Clinical Research
Functional Area: CR
Last Date: 30th August, 2014
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