Clinical Training Coordinator I (4511)

The Clinical Training Coordinator I serves as an instructional liaison and operational support lead in the planning, delivery, and oversight of clinical training programs. This position is responsible for conducting training needs assessments, managing the Learning Management System (LMS), facilitating new hire clinical onboarding, and developing structured content for Quality Management Documents (QMDs) and role-based training modules. Working in close collaboration with QACE, Site Operations, HR, and Organizational Development teams, ensures standard clinical procedures, regulatory compliance, and high-quality instructional initiatives across all sites.

DUTIES & RESPONSIBILITIES

1. Coordinate with HR, Organizational Development, QACE, Site Management, and Central Services teams to plan and execute standardized clinical training programs across all sites.

2. Conducts needs assessments, skills gap analyses, and instructional analysis to ensure alignment with mission training objectives.

3. Conducts ongoing training programs derived from performance evaluations, career development plans, quality assurance/control (QA/QC) data trends, monitoring reports, and protocol updates.

4. Conducts and coordinates internal staff sessions, and study-specific training in collaboration with site management and the Clinical Training Team.

5. Coordinates in-person mentoring programs for site employees.

6. Responsible for managing and facilitating clinical onboarding for new hires upon completion of initial HR-driven onboarding, ensuring seamless integration into site roles.

7. Responsible for managing, maintaining, and administering the Learning Management System (LMS), including tracking completions, uploading content, running status reports, and managing user records.

8. Creates and curates content for Quality Management Documents (QMDs), SOPs, and structured role-based training modules.

9. Prepares auxiliary plans for instructional projects, including comprehensive scripting, storyboarding, timelines, procedural manuals, and auxiliary support materials.

10. Prepares training status reports, exhibits, desk procedures, and tracking communications as required by leadership.

11. Maintains up-to-date working knowledge of FDA regulations, ICH-GCP guidelines, DMCR internal SOPs, protocol changes, and regional regulatory requirements.

12. Completes all required organizational training on a timely basis, including ICH-GCP Certification and IATA certifications.

13. Participates in monthly Clinical Training team meetings, continuing education, and periodic professional seminars or forums to stay current on learning technologies and methodologies.

14. Performs other training-related duties as assigned.

KNOWLEDGE & EXPERIENCE

Education:

● Bachelors degree in health, life sciences, or a related field.

● An equivalent combination of education and four (4) years of experience in a clinical research setting may substitute for the degree requirement.

Experience:

● Minimum 1–2 years of experience in clinical research training, HR, presentation/instructional delivery, or related clinical trials experience.

● Experience creating learning content, administering LMS platforms, or executing clinical onboarding programs is preferred.

Credentials:

● N/A

Knowledge and Skills:

● Proficiency in managing and navigating Learning Management Systems (LMS) and electronic data capture systems.

● Strong ability to analyze, design, script, and implement effective role-based training modules and instructional materials.

● Excellent written, verbal, and presentation skills with an ability to teach cross-functional groups.

● Adept with a variety of multimedia training platforms, presentation tools, and Microsoft Office Suite (Word, PowerPoint, Outlook).

● Strong organizational, time management, and problem-solving skills with high attention to detail and ability to meet deadlines.

● Comprehensive understanding of FDA regulations, GCP/ICH guidelines, and clinical trial compliance standards.

KPI & Success Metrics

● Delivers 90%+ of planned QMDs, SOPs, and role-based training modules on or before deadline.

● Ensures 100% of QMDs, training manuals, and modules reflect current regulatory standards with zero outdated document versions active.

● Maintains 98–100% data accuracy and audit readiness across all LMS employee records and training logs.

● Logs training completions, attendance rosters, and assessment records within 24–48 hours of session delivery.

● Achieves 95% on-time completion rate for new hire clinical onboarding within 30–60 days.

● Maintains a 90% completion rate for assigned role-based modules and required refresher courses.

● Decreases training-related audit findings, documentation errors, and protocol deviations across supported sites.

● Maintains a 100% active compliance rate for mandatory certifications (ICH-GCP, IATA).