About the job
Role: Clinical Research Associate (CRA) B
Location: Alameda, CA 94502
Duration: 06+ Months 100% Onsite role. 25 to 30% travel involved on an average across the US.
Skills Looking For:
- CRA Monitoring experience.
- Responsible for monitoring, and studying data and trial master files, as well as device countability.
- Experience with Electronic Data Capture or EDC and electronic trial master files will be a big plus.
- Performing study site visits that would include qualification visits, initiation visits, interim monitoring visits, and closeout visits.
- Responsible for generating those monitoring reports and tracking the resolution of action items that they identify during those visits.
- They would monitor to ensure compliance to our study protocol to good clinical practices to the ICH guidelines, Federal regulations and other supplicatory regulatory requirements.
- Help the site and Abbott for inspection readiness and audit trial master file; perform a review or with their managers, perform a review of clinical data listings from the study they’re working on for completeness and accuracy.
- Communicate the status of each clinical study at their assigned sites to management and escalate any action items they feel need to be escalated. At the end of the study, they would participate in interim and final reviews of the study data.
- 30% travel involved on average: anywhere across the US depending on the study.
Education and Experience:
- Bachelor’s degree preferred with 3 to 5 years of Clinical Research Monitoring experience; will also consider bachelor’s with 2 yrs. exp if they have all desired skill sets.
- Open to an associate degree with a minimum of 5 years of Clinical Research Monitoring experience.
- Clinical Research Monitoring experience in the Med device/Pharma industry.
- Attention to detail.
- Organizational skills.
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