Clinical Research Associate II

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 |

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