Sr. Clinical Research Associate - Ghent, Flemish Region

Alleen voor geregistreerde leden Ghent, Flemish Region, België

3 dagen geleden

Functieomschrijving

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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