The regionally based Clinical Research Associate operates out of a home based office and travels to the study sites to perform field monitoring of ongoing clinical investigations in compliance with FDA regulations, Good Clinical Practices (GCPs), and our Client's SOPs to ensure adequate protection of the rights and safety of human subjects and data integrity. Regional Position that will cover OH, VA, KY.
Minimum of BS (RN or Life Science preferred)
At least 2 years field monitoring experience
Working knowledge of Good Clinical Practices (GCPs), the Code of Federal Regulations (CFR) and the Internal Conference on Harmonisation (ICH) guidelines as they relate to the conduct of clinical trials.
Proficient computer skills: i.e.< MS Office/ Outlook/ EDC applications/ Clinical Trial Management System
Must have experience with maintaining a professional home office: Laptop, Printer/Scanner/Fax/Photo Copier, Cell phone/ Internet access etc.
Respiratory experience preferred - asthma, COPD, spirometry experience major plus
Up to 80% travel
Essential Duties & Responsibilities:
Conducts all applicable site visits: Pre-Study, Site Initiation, Interim Monitoring and Close Out
Manages day to day responsibilities of a clinical trial under the supervision of the CTM
Provides and maintains clinical study support to internal study team and Investigational study sites
Assists in house study team with development of study specific monitoring tools
Performs co-monitoring visits and trains/mentors study team members
Participates in non-project process development
Follows our clients Safety, Health, and Environmental policies and procedures
Other duties as assigned or as business needs require.
About OV Clinical Trials:
OV Clinical Trials is a clinical service organization specialized in Clinical Research Staffing and performing alternate site clinical trials.