Job Title: Senior Clinical Research Associate
Location: Taipei City (Remote)
Department: Clinical Services – Clinical Operations - Monitoring & Site Management
Employment Type: Full-time, Permanent
Working Conditions: Home-based with regular travel
Accommodations: Available upon request throughout the recruitment process
Job Summary:
The Senior Clinical Research Associate (Sr. CRA) will manage, deliver, and/or perform full clinical site monitoring services for one or more projects, including multinational and complex projects. The role involves overseeing project monitoring services such as site/patient recruitment, site data/document management, regulatory filings, and budget monitoring in alignment with SOPs, study guidelines, and GCP best practices. In the Lead CRA capacity, the Sr. CRA will act as the primary liaison between CRAs and the project team and may assist with project plans, protocols, CRFs, communications, and other monitoring documents.
Key Responsibilities:
Monitoring - Subject Matter Expert
Act as a subject matter expert (SME) and provide mentorship, coaching, and performance feedback to peers.
Assist with the selection, hiring, training, and supervision of CRAs as needed.
Perform co-monitoring and training visits with CRAs.
Serve as the first escalation point for site/patient issues or sponsor concerns.
May represent the Director, Monitoring and Site Management, or Manager, Clinical Site Management in BD initiatives with a site monitoring focus.
Project Monitoring Lead
May assume the role of Lead CRA, managing monitoring services for a group of projects and/or CRAs, especially in large/complex projects.
Direct and guide the day-to-day activities of CRAs, review, and approve monitoring reports.
Function as a liaison between CRAs and other functional teams, escalating concerns as necessary.
Participate in or present at study team, kickoff, and investigator meetings, and act as the primary contact for sponsors regarding monitoring-related issues.
Site Recruitment and Setup
Identify and recruit site investigators, and coordinate the movement and delivery of trial materials, including investigational products, protocols, SOPs, CRFs, and project-related documents.
Optimize patient recruitment by ensuring SOPs are in place and guiding site teams on inclusion/exclusion criteria.
Investigational Site Monitoring:
Serve as the primary clinical site contact for any issues or questions.
Promote positive working relationships with site staff and ensure study integrity.
Assist site staff with access to study systems and ensure compliance with training requirements.
Ensure site-related issues are addressed and resolved promptly.
Coordinate the delivery of communications to clinical sites, ensuring that investigational sites receive accurate ongoing data, updates, and feedback throughout the project lifecycle.
Qualifications:
Education: Minimum of a college diploma/degree.
Experience: 4-6 years of related experience in clinical monitoring.
Skills:
Self-motivated with strong communication skills.
Strong attention to detail and a focus on collaborative relationships.
Ability to engage in continuous learning and self-development.
Ability to foster teamwork and drive positive results.
Language Proficiency: Fluent in reading, writing, and speaking English.
Working Conditions
Home-based position with regular travel.
How to Apply
Interested candidates should apply via the Alimentiv website.
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