The Lead CRA will be the organizations main point of contact for investigative sites as well as accountable for safeguarding the quality and patient safety at the investigator site. The consultant is responsible for site monitoring and oversight and building and retaining relationships from site activation through the lifecycle of studies. As part of the oversight responsibilities, the consultant will utilize and interpret 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 consultant is also accountable for identifying CRA performance issues and is responsible for ensuring appropriate corrective and preventative actions are put in place. The Site Relationship & Excellence Partner consultant is the “face of the organization” and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and the organizations reputation is that of “Partner of Choice.”
SCOPE OF WORK:
Responsible for relationship building and management
- Usher investigator sites through site activation and study activities from study start up to close out.
- Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback.
- Act as the main point of contact for all site- and study-level questions, liaising with and escalating to appropriate teams to respond and resolve questions. Follow up and close issue status with investigators to ensure awareness of resolution.
- Inform and educate investigator sites of the organizations pipeline opportunities that may be a good fit.
- Lead effective site recruitment planning and implementation of plans at the country- and site-level, consistent with global plan and local targets.
- Demonstrate leadership within the local clinical development environment with a goal to enhance the organizations reputation in scientific leadership.
Responsible for proactively providing local intelligence
Accountable for study start-up, activation, and execution to plan for targeted sites
For all sites:
- Provide enrollment support and ensure progress by responding to start up and recruitment issues from investigators, partner with study team to define and support recruitment initiatives at site / country level.
- Maintain a thorough knowledge of assigned protocols.
- Proactively identify, manage and escalate site issues related to study delivery, triaging and coordinating communications and resolution efforts by the organizations colleagues.
- Support database release by facilitating query resolution, as needed.
- Actively pursue possible efficiencies and develop best practices in the delivery activities for site start up and performance at the targeted site level to increase investigator/site satisfaction and strengthen targeted site relationships with the organization.
- Seek assignment to complex protocols due to demonstrated capability in responsibilities.
Responsible for CRO and Study Management Interface
Responsible for process, standards, and oversight:
- Responsible for site and monitoring quality, regulatory and 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 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 the organizations 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 CRO CRAs, and other CRO 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 the organizations processes.
- Review of monitoring visit reports.
- Serve as key contributor to process improvement initiatives and may lead local area initiatives.
- Support in external environment shaping activities for a country.
- Act as a Subject Matter Expert for a category or global processes within the GSSO organization.
- Support onboarding of new colleagues in country.
Protocol Site Oversight
Site and Study Management Interface
- Serve as point of contact for quality and safety escalations for CRO, CRAs, Site Relationship Partner and Study Team.
- Support vendor relationship management at country-level.