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- Site Excellence Partner (FSP) - 0.5 FTE
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Site Excellence Partner (FSP) - 0.5 FTE
Parexel International Corporation
Multiple Locations
Position Purpose:
The Site Excellence Partner (SEP) is accountable for safeguarding the quality and patient safety at the investigator site and is responsible for site and monitoring oversight
The SEP is responsible for utilizing and interpreting data from analytic tools, in conjunction with country and regional intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks
The SEP is accountable for identifying Clinical Research Associate (CRA) performance issues and is responsible for ensuring appropriate corrective and preventative actions are put in place
The SEP may be required to support some or all of the primary responsibilities of the Site Relationship Partner (SRP), as example, proactively collaborating and providing local intelligence to country outreach surveys, targeted sites strategies, study design, and Client pipeline opportunities
The SEP may be required to support additional primary responsibilities of the SRP in study start up, activation, and execution to the plan for targeted sites, helping coordinate with other roles and functions that will interface with target sites, thereby, simplifying site Client communications and enhancing overall visibility into and confidence of quality of site-level activities
Primary Duties:
Responsible for process, standards and oversight for assigned studies
Responsible for site and monitoring quality, regulatory and Good Clinical Practice (GCP) compliance
Drive inspection readiness and provide support for site audits/inspections as needed, following through audit/inspection finding to resolution
Follow the study oversight plan and proactively put in place mitigations for known/anticipated risks.
Responsible for site and monitoring quality using and interpreting signals identified by Signal Interpretation Leads in conjunction with local country intelligence to proactively identify risks
Lead risk assessment at the site/country level for their studies, including identifications of mitigation and control
Maintain knowledge of appropriate tools and resources (e.g., metrics, site health, Risk Based Monitoring signals, etc.)
Demonstrate use of data to enhance quality and accelerate study delivery.
Apply knowledge of data and analytics to target site and study, recommend and implement actions for mitigation and control
Conduct and report oversight activities, both remote and onsite visits, according to Client requirements and standards
Perform additional oversight visits/reviews based on the type of issues that arise during the course of a study, and the analytics and visualizations outputs
These may be conducted with the assigned CRA or alone depending on the nature of the issue(s).
Work with Provider CRAs, and other Provider colleagues as appropriate, to drive resolution of oversight issues
Accountable for identifying site and CRA performance issues and quality events and other quality issues at patient and/or site level, escalating, and supporting implementation of CAPAs to address these
Demonstrates the learning culture by ensuring site quality and trends, including preventive actions are shared across study & assets in the portfolio to drive accelerated drug delivery
Identify potential improvements for Client processes
Review of monitoring visit reports
Protocol Site Oversight
Maintain a thorough knowledge and understanding of assigned protocols, including associated risks and mitigations, as it relates to site and monitoring quality
Attend Investigator meeting/protocol training to ensure clear understanding of the protocol requirements
Site and Study Management Interface
Support local Investigator relationship management with the Site Relationship Partner.
Serve as point of contact for quality and safety escalations for Provider, CRAs, Site Relationship Partner and Study Team
Support the resolution of operational obstacles at the site/country level in order to advance the site and study deliverables
General
Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training
Adhere to EP and Client SOPs and processes
The Individual:
A scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodology
Solid knowledge of clinical development processes with strong emphasis on monitoring
Demonstrated ability to oversee a 3rd party and/or demonstrated ability in Quality Assurance (preferred)
Site Management/Monitoring (CRA) experience (preferred)
Project management experience preferred in the clinical development area
Ability to lead, troubleshoot and influence for delivery
Independent approach
Demonstrated knowledge of clinical research processes and global and local regulatory requirements; ability to gain command of process details
Demonstrated ability to work in cross-functional matrix environment
Ability to evaluate, interpret and present complex issues and data to support assessment and mitigation of site risk
Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
Considers stakeholders including regulatory agencies and marketing when developing strategies and future directions
Challenges people to surpass themselves in reaching their objectives using innovative solutions
Utilizes and encourages innovative approaches to build and maintain a competitive advantage
Acts as a champion of change across the area/region/countries; uses facts, logic and personal credibility to influence the successful implementation of process improvements
Builds wide networks and alliances; utilizes stakeholder input to develop strategic thinking and find opportunities for collaboration
Respectfully challenges practices, decisions or ideas to uphold integrity and ethical standards
Exhibits behaviors consistent with company values to colleagues at multiple locations with diverse cultures
Motivates through example, commitment, loyalty and enthusiasm
Availability to travel regularly within country and region is required
Fluent English
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Job posted: 2022-10-18