Summary

• The CRA B will assist in the clinical execution and management of all aspects of assigned clinical studies.
• This includes but not limited to planning and implementation of clinical studies from concept to clinical study report per timelines and quality standards.
• This is an on-site position in Alameda, California. This is not a remote position.

Essential Duties and Responsibilities

• Conduct single or multi-center medical device clinical studies.
• Perform study site visits (SQV, SIV, IMV, COV), ensuring compliance to the Study Protocol, Good Clinical Practices (GCPs), ICH guidelines, Federal Regulations, department procedures and applicable regulatory requirements, generating monitoring trip reports, and track resolution of action items.
• Participate in study start up activities.
• Responsible for ensuring shipment of study devices and supplies to clinical sites and performing study device accountability.
• Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), selection and training of investigator sites, planning and running study meetings, evaluation, selection, and training of new study investigators.
• Maintain and audit Trial Master File to ensure inspection readiness.
• Perform review of clinical data listings for completeness and accuracy, and escalate issues to the Clinical

Operations Manager as needed

• Participate in cross-functional clinical team(s) in the planning and execution of clinical trials.
• Proactively and effectively communicate the status of clinical studies to management.
• Ensures quality delivery of study deliverables within agreed budgets and timelines.
• Participate in the interim and final reviews of study data in preparation of regulatory submissions.
• Involved in the preparation of all applicable documents required for the conduct of the study (such as Trial Master File (TMF), Clinical Protocols and Reports).
• May interact with RA/QA in responding to audits and FDA inquiries.

Education and Experience

• BS degree in life sciences with three years of experience as a CRA or CRC or combination of appropriate

education and experience required.

• Must have 3+ years of relevant experience in site monitoring, clinical trial practices and regulations.
• Experience in conducting medical device and/or in-vitro diagnostics studies. Pharmaceutical background may also be considered.

Skills

• Demonstrated excellence in teamwork, shared mindset for success, stellar interpersonal and communication skills including building rapport with team members, peers, and management.
• Solid understanding and demonstrated experience of the clinical trial process including study design and conduct; clinical data management systems; clinical trial management systems; data analysis; and data reporting and interpretation.
• Must have a demonstrated ability to solve problems with innovative solutions along with strong project management and organizational skills to deliver projects on time and on budget.
• Able to manage numerous projects/conflicting priorities, and to be flexible when priorities change.
• Working knowledge of GCP, Clinical and Regulatory Affairs.
• Flexibility in daily activities.
• Proficient with Microsoft Suite.

Travel Requirements

• Must be able to travel 30-50%