Manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale. In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices. In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. Represents the corporation by maintaining collaborative relationships with stakeholders.
Monitoring - Subject Expert
- Act as subject matter expert, mentor, coach and/or provide performance feedback to manager for peers.
- Assist with selection, hiring, training, and supervision of CRAs as needed. Perform co-monitoring and training visits with CRAs.
- When required, act as the first escalation point for the resolution of site/patient issues or to address Sponsor concerns.
- May represent Director, Monitoring and Site Management or Manager, Clinical Site Management in BD initiatives with a site monitoring focus.
Project Monitoring Lead
- May be assigned Lead CRA role and manage monitoring services for a group of projects and/or CRAs on large/complex project(s) including directing/guiding day to day activities and review/approval of monitoring reports.
- Function as liaison between CRAs and other functional teams, escalating concerns and issues to management as needed.
- Participate and/or present at study team, kickoff and investigator meetings and act as primary contact to sponsors for all monitoring related issues.
Site Recruitment and Setup
- Identify and recruit site investigators, coordinate the movement and delivery of trial materials, samples, tests and forms, including investigational product, protocols, SOPs, CRFs, project documents, forms and support tools.
- Ensure SOPs in place to optimize patient recruitment providing guidance to site teams of inclusion/exclusion criteria.
Investigational Site Monitoring
- Primary clinical site contact.
- May act as primary contact for any questions or issues that arise from investigational sites.
- Oversee overall integrity of the study to promote positive working relationships with the site and staff.
- Facilitate and support site staff with access to study systems and ensure sites are compliant with project specific training requirements.
- Ensure all site related issues are followed until resolution.
- Coordinate delivery of clinical sites communications, collaborating with project teams, to ensure investigational sites are provided accurate ongoing data, updates, information and feedback on project/regulatory guidelines and objectives throughout the project lifecycle.
Qualifications
- The successful candidate will possess a minimum of a college diploma/degree and 4-6 years of related experience.
- Self-motivation with strong communication skills and a commitment to achieving positive results.
- Strong attention to detail and keenness to understand the importance of building collaborative relationships to achieve results.
- Critical thinking abilities
- Ability to regularly travel to sites.
Working Conditions
- Home-based
- Regular travel is required
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Originally posted on Himalayas