At PAREXEL, we believe that the power to work independently and intelligently should be yours every day. Your ability to understand our clients’ needs and achieve quality results is critical to our reputation as one of the best clinical research organizations (CROs) in the world. As a Clinical Research Associate (CRA) within PAREXEL's Global Monitoring Operations Group, we support you with leading-edge technology, the highest caliber team members, and managers who know your strengths.
Post : Clinical Site Manager II
Job Description
• Perform all clinical monitoring/site management activities for assigned projects in accordance with PAREXEL's standard operating procedures
• Act as PAREXEL's direct contact with assigned clinical sites, and use judgment to assess and ensure overall integrity of study implementation, as well as adherence to study protocol
• Conduct qualification visits (QV), site initiation visits (SIV) and monitoring visits (MV) at assigned clinical sites
• Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Function as a mentor and role model for other CRA team members
• Manage clinical monitoring activities, including:◦Arranging on-site visits and logistics
• Establishment of a site recruitment plan in collaboration with site staff during QV
• Monitoring completeness and quality of Regulatory Documentation
• Performing site documentation verification
• Data collection and drug accountability in accordance with ICH GCP guideline
• Monitoring patient safety on-site and addressing any violations in a timely manner
Candidate Profile
• Minimum 2 years of monitoring experience in clinical research
• Educated to degree level (biological science, pharmacy or other health related discipline)
• Strong working knowledge of EDC systems and IVRS
• Experience of CTMS preferred
• Competent in written and oral English
• Minimum 2 years of monitoring experience in clinical research
• Educated to degree level (biological science, pharmacy or other health related discipline)
• Strong working knowledge of EDC systems and IVRS
• Experience of CTMS preferred
• Competent in written and oral English
Additional Information:
Location: India
Education: B.Pharm, B.Sc
Job ID : 43024BR
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Clinical Site
End Date: 24th July, 2018
Location: India
Education: B.Pharm, B.Sc
Job ID : 43024BR
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Clinical Site
End Date: 24th July, 2018
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