Description
The Senior Clinical Research Associate will report to the Clinical Project Manager. Primary Responsibilities include:- Oversee study monitoring and occasionally co-monitor study sites
- Participate in investigator site selection and vendor selection
- Assists in managing CRO activities
- Participate in review of site budgets and contracts
- Participate in the review and implementation of departmental SOPs
- Review study specific plans and Informed Consent templates
- Insures clinical supplies are authorized for shipment to investigational sites
- Documents and maintains all relevant site communications and vendor communications
- May be the lead monitor on assigned protocols and/or projects
- Aware of and follows company SOPs, GCPs, FDA regulations and ICH guidelines
- Reviews literature as required
- Provides study status reports and tracker to management
- Assists in the preparation and completion of IND, and NDA documents, as well as product annual reports and final safety reports as required
Skills & Education Requirements:
- Nursing Degree (R.N. or B.S.N), Life Sciences (B.S. or B.A.), Pharmacy or Medicine required
- Minimum of 6+ years clinical research experience within the pharmaceutical and/or biotech industry (preferably small company)
- 4+ years of site monitoring experience required
- Global clinical trial experience desired
- Thorough understanding of FDA regulations, ICH Guidelines and GCPs
- Exceptional communication skills; ability to communicate effectively with all levels of the organization
- Proficiency in Excel, Word, PowerPoint, Share Point and MS Project
To find out more about Real please visit www.realstaffing.com