Site and Monitoring Health Lead - FSP
When our values align, there's no limit to what we can achieve.
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.
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.
Summary of Key Responsibilities:
Employ risk-based thinking to focus on what is critical to quality, and exhibit an “inspection ready at all times” mentality
Create Study Specific Oversight Plans (SSOP) for aligned trials in scope and/or follow SSOP when conducting oversight activities
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
Build relationships with investigators and site staff in region; act as a resource for identifying potential sites for new studies
Utilize root cause analysis to assess identified issues and provide suggested actions to Study Management / CRO to mitigate risk
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
Troubleshoot and use alternative and innovative approaches to solve problems impacting clinical site delivery and quality
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
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
Support inspection preparation and management
Maintain awareness of changes in industry and regulatory standards for GCP requirements
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.
Requirements
Bachelor's Degree is required. A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD,) is preferred
Previous direct monitoring experience gained with a CRO or pharmaceutical company working on multinational clinical studies; Lead CRA/management experience preferred
Experience in all study phases of clinical research (Phase I-III) and experience in both prevalent and rare medical conditions preferred
Previous audit and regulatory inspection experience preferred
Comprehensive and current regulatory knowledge, including GCPs
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.
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.
Summary of Key Responsibilities:
Employ risk-based thinking to focus on what is critical to quality, and exhibit an “inspection ready at all times” mentality
Create Study Specific Oversight Plans (SSOP) for aligned trials in scope and/or follow SSOP when conducting oversight activities
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
Build relationships with investigators and site staff in region; act as a resource for identifying potential sites for new studies
Utilize root cause analysis to assess identified issues and provide suggested actions to Study Management / CRO to mitigate risk
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
Troubleshoot and use alternative and innovative approaches to solve problems impacting clinical site delivery and quality
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
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
Support inspection preparation and management
Maintain awareness of changes in industry and regulatory standards for GCP requirements
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.
Requirements
Bachelor's Degree is required. A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD,) is preferred
Previous direct monitoring experience gained with a CRO or pharmaceutical company working on multinational clinical studies; Lead CRA/management experience preferred
Experience in all study phases of clinical research (Phase I-III) and experience in both prevalent and rare medical conditions preferred
Previous audit and regulatory inspection experience preferred
Comprehensive and current regulatory knowledge, including GCPs