Clinical Research Associate monitoring clinical trial sites for Parexel, a global clinical research organization. Ensuring patient safety, data quality, regulatory compliance, and site delivery.
Responsibilities
Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV), and termination visits (TV) at assigned clinical sites
Generate visit and contact reports
Build and maintain site relationships as the site's primary point of contact
Address and resolve site issues and questions
Oversee study integrity and promote rapport with site staff
Review trial performance and safeguard the rights and well-being of human subjects in accordance with the protocol
Develop patient recruitment strategies with clinical sites to meet enrollment timelines
Ensure compliance with SOPs, protocols and amendments, GCP, and applicable regulatory requirements
Evaluate reported data quality and integrity, site efficacy, and drug accountability
Monitor completeness and quality of regulatory documentation
Perform site document verification
Manage site quality and delivery from site identification through close-out
Requirements
18+ months of direct onsite monitoring experience as a Clinical Research Associate (CRA)
Bachelor's or equivalent degree in biological science, pharmacy, or another health-related discipline
Strong interpersonal, written, and verbal communication skills within a matrixed team
Ability to work independently with a sense of urgency and limited oversight
Client-focused approach with flexibility regarding assignments and new learning
Ability to manage multiple tasks, evaluate unpredictable scenarios, achieve project timelines, and apply understanding of study protocols
Honest and ethical work approach
Strong computer skills, including Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS), Microsoft Excel, and Microsoft Word
Benefits
Bonus incentive program
World-class technology
Training catered to individual experience
Less travel and lower protocol load compared to industry peers
Opportunities to work within multiple therapeutic areas
Career advancement opportunities
Career growth support through performance discussions and evaluations
Opportunities to progress into senior CRA, line management, Quality, Project Leadership, or other positions
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