Job Title: Clinical Research Associate II
Duration: 12+ months with possible extension
Location: Sunnyvale-CA
• Maintain all Study Documentation, Assist Principal Investigator(s) with IRB submissions & applications such as new submissions, Continuing Review Application, Amendments, Deviation Reports, and/or Adverse Event reporting
• Provide guidance to a large Study Staff
• Coordinate & conduct yearly training activities, and ongoing training needs (updates, new staff)
• Coordinate and oversee regular Monitoring visits
• Be main point of contact for research volunteers
• Coordinate recruitment efforts
• Consent Volunteers
• Maintain facilities (consent area, scan bays) to ensure compliance
• Implement process improvement activities as needed
• Implement electronic processes to facilitate compliance and efficiency
• As SME for global protocols, provide support to Global Program Manager, Ultrasound Internal Research as needed
• Serve as a Subject Matter Expert (SME) for coordinators at global sites executing similar protocols
Qualifications/Requirements 1. Bachelor's degree in science or research related fields
2. Previous experience with a minimum of 3-years in clinical research
3. Outstanding organizational skills
4. Proficient at managing Excel spreadsheets/trackers
5. Possess a high level of attention to detail
6. Exceptionally well-organized
7. Excellent communication skills (written and verbal)
8. Must be legally authorized to work in the United States full-time
10. Must be 18 years of age or older
Desired Characteristics 1. CCRC or CCRP certified preferred
2. Previous experience as a Clinical Study Coordinator
Many Thanks
Ali Khan
APN Software Services Inc.
39899 Balentine Drive Suite 385 Newark CA 94560
Direct: 510.870.8798 | Fax: 510.623.5055 | ali@apninc.com