<p><b>When our values align, there's no limit to what we can achieve.</b><br> <br>At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.</p><p>Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.</p><p></p><p></p><p><b>Summary of Key Responsibilities:</b></p><ul><li><p>Employ risk-based thinking to focus on what is critical to quality, and exhibit an “inspection ready at all times” mentality</p></li><li><p>Create Study Specific Oversight Plans (SSOP) for aligned trials in scope and/or follow SSOP when conducting oversight activities</p></li><li><p>Implement various types of oversight encounters and activities as applicable including but not limited to: site risk analysis, site contacts, aggregate review of data, monitoring visit report review, Sponsor Oversight Visits, system/data spot checks, and periodic summaries; ensure timely documentation of these activities is completed and filed</p></li><li><p>Build relationships with investigators and site staff in region; act as a resource for identifying potential sites for new studies</p></li><li><p>Utilize root cause analysis to assess identified issues and provide suggested actions to Study Management / CRO to mitigate risk</p></li><li><p>Support investigator sites less experienced in research; assist in assuring sites are engaged in the study and have what they need to recruit participants successfully</p></li><li><p>Troubleshoot and use alternative and innovative approaches to solve problems impacting clinical site delivery and quality</p></li><li><p>Work closely with Clinical Risk & Analytics staff to understand the risk management plan (Risk MAP) for assigned studies, ensure the SSOP is aligned with the Risk MAP, and assess sites who are outliers</p></li><li><p>Lead oversight and trend meetings with the study team and/or CRO to discuss risks, issues, and trends identified by the SMH team for the trial</p></li><li><p>Support inspection preparation and management</p></li><li><p>Maintain awareness of changes in industry and regulatory standards for GCP requirements</p></li><li><p>Travel on assignment ~ 50% is required. This is a site facing position and travel may fluctuate up or down depending on business need. May include local, regional and international travel.</p></li></ul><p></p><p><b>Requirements </b></p><ul><li><p>Bachelor's Degree is required. A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD,) is preferred</p></li><li><p>Previous direct monitoring experience gained with a CRO or pharmaceutical company working on multinational clinical studies; Lead CRA/management experience preferred</p></li><li><p>Experience in all study phases of clinical research (Phase I-III) and experience in both prevalent and rare medical conditions preferred</p></li><li><p>Previous audit and regulatory inspection experience preferred</p></li><li><p>Comprehensive and current regulatory knowledge, including GCPs</p></li></ul><p></p><p></p>