Regional Specialist
Job Overview
Regional Specialists (RS) are an integral part of remote visit delivery, liaising with clinical teams, clinicians, and investigator sites for remote visits. The RS works in partnership with the RNPS Lead providing support with remote visit activities to mitigate risk, control cost, manage project schedule, and ensure customer satisfaction related to assigned project/s.
Essential Functions
Site and Nurse Onboarding
Regional Specialists (RS) are an integral part of remote visit delivery, liaising with clinical teams, clinicians, and investigator sites for remote visits. The RS works in partnership with the RNPS Lead providing support with remote visit activities to mitigate risk, control cost, manage project schedule, and ensure customer satisfaction related to assigned project/s.
Essential Functions
Site and Nurse Onboarding
- Conduct outreach and training for investigator sites opting into RNPS services.
- Train and onboard research clinicians, ensuring they are prepared and study-ready.
- Manage access to systems like Study Hub and Thinking Cap for both site staff and clinicians.
- Receive and process Visit Request Forms (VRFs).
- Assign and confirm clinicians for remote visits.
- Coordinate visit logistics including supplies, equipment, and courier services.
- Ensure all required documentation (e.g., DOA logs, nurse credentials) is complete and uploaded.
- Maintain and update Smartsheet trackers for sites, visits, and nurses.
- Perform quality checks on source documents and ensure timely corrections.
- Review uploaded documents in Study Hub and notify relevant stakeholders.
- Deliver study-specific training to sites and clinicians.
- Ensure compliance with GCP, ICH, HIPAA, and IQVIA SOPs.
- Serve as the primary liaison between sites, nurses, and internal study teams.
- Provide ongoing support and retraining to nurses as needed.
- Escalate issues to RNPS Lead and ensure resolution.
- Book and track courier shipments for study drug, samples, and documents.
- Manage inventory and supply needs for nurses and depots.
- Bachelor's Degree Life sciences or other related field Req
- Typically requires 0 - 2 years of prior relevant experience.
- Requires knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education.
- 1 year of relevant clinical research experience with visit coordinator skills or relevant Project Management experience or equivalent combination of education, training, and experience.
- Knowledge of clinical trials - knowledge of clinical trial conduct and skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH), Good Clinical Practice (GCP), relevant local laws, regulations, and guidelines, towards clinical trial conduct.
- Communication - strong written and verbal communication skills including good command of English language.
- IT skills - good software and computer skills, including Microsoft Office applications, including but not limited to, Microsoft Word, Excel, and PowerPoint.