The FSP Clinical Trial Coordinator (CTC) II, serving as a Project Specialist, is a key contributor to clinical study success. This role supports end-to-end operational study delivery, from setup to archival, within Fortrea’s PPD® clinical research portfolio, an industry-leading global CRO. The CTC II ensures inspection readiness, quality control, and effective stakeholder communication, partnering closely with study managers and delivery leads to optimize study timelines and outcomes.
Key Responsibilities
- Study Delivery Support
- Collaborate with Study Managers or Delivery Leads on study planning and tracking, ensuring data accuracy in internal systems and databases.
- Monitor study conduct and progress, promptly identifying and addressing risks that may affect quality, budget, and timelines.
- Document and Quality Management
- Review and develop key clinical documents such as the Protocol, Informed Consent Forms, and study plans (e.g., Monitoring, Vendor Management, and Risk Management Plans).
- Oversee eTMF setup and periodic reviews to ensure completeness, quality, and inspection readiness.
- Vendor and CRO Oversight
- Act as the primary point of contact for vendor management, overseeing deliverables, and ensuring timely monitoring and completion of outsourced activities.
- Country and Site Oversight
- Monitor recruitment progress, compliance, and regulatory approvals, coordinating closely with local teams for accurate tracking and issue resolution.
- Team and Communication Management
- Organize meetings, maintain communication logs, track team actions, and distribute newsletters to ensure consistent information flow among stakeholders.
- Supply and Data Oversight
- Ensure the timely delivery of clinical supplies, investigational products, and materials, proactively addressing any potential risks to continuity.
- Budget Management
- Oversee budget elements like task orders, expenses, and tracking updates, aligning with systems and agreements to maintain financial compliance.
Required Education and Experience
- Education: Bachelor’s degree in Life Sciences or a related field.
- Experience: At least 1 year of relevant experience in a clinical research or pharmaceutical setting, with knowledge of ICH-GCP and clinical study processes.
Skills and Qualifications
- Clinical Knowledge: Foundational knowledge of clinical trial processes, regulatory requirements, and industry standards.
- Project Management: Strong skills in managing multiple priorities and ensuring timely study delivery.
- Technical Proficiency: Proficiency with Microsoft Office (Excel, PowerPoint, Word), clinical trial management systems, and eTMF standards.
- Communication and Stakeholder Management: Excellent verbal and written communication skills in English, with strong interpersonal abilities.
- Analytical and Problem-Solving: Logical, independent thinking with a risk-based approach and quality-focused mindset.
