Description
Responsibilities:- Independently manages the study start up activities for a multi-center, US based diagnostic study currently enrolling
- Responsible for the clinical site training and sites adherence to protocol, all applicable GCP/ICH guidelines, regulations statutes and SOPs.
- Independently creates project specific documents and tools - e.g., Monitoring Guidelines, Meeting materials/manuals, tracking spreadsheets/databases, training tools/materials, etc.
- Mentor and coach junior staff new to Clinical Research; CTAs
- Assists with the development of new diagnostic studies, including protocol writing, informed consent development, plans, CRFs, monitoring conventions, tracking forms, and other study related documents
- Conduct study qualification visits for the purpose of assessing the site's ability to effectively conduct the trial as per SOPs and study guidelines.
Skills / Education:
- Excellent verbal and written communication skills. Excellent organizational, record retention, time management, decision making, customer service, and interpersonal skills. Good command of written and spoken English language
- Experience managing large clinical studies and working with CROs, a big plus
- Ability to travel domestically as required (up to 35%)
- BS/BA, RN, or equivalent with at least 5 years clinical trial monitoring experience (diagnostic experience preferred) in accordance with CFR, GCP and ICH Guidelines
To find out more about Real please visit www.realstaffing.com