Description
Primary Responsibilities include:- Track progress of study including patient enrollment, monitoring visits
- Review key study quality metrics (e.g., eligibility, tumor assessments, primary endpoint data, etc.)
- Investigate queries, monitor discrepancies
- Manage investigational product (IP) accountability and reconciliation process
- Responsible for review or approval of IP release packages
- Negotiate and manage the budget and payments for investigative sites, if applicable
- Clinical data review of data listings and summary tables, including query generation, follow up, and resolution
- Oversee performance of CROs, third party vendors, and field CRAs to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to manager or CRO as appropriate
Skill Requirements:
- Bachelors Degree required; Life Science degree preferred
- Strong computer skills (MS Office)
- Strong working knowledge of FDA & ICH/GCP regulations and guidelines
- Thorough knowledge of clinical monitoring procedures
- Strong analytical and assessment skills
- Strong judgment and problem solving skills
To find out more about Real please visit www.realstaffing.com