Clinical Research Associate/Monitor
Foster City, CA US
Under the direction of the Associate Director of Clinical Operations and the Clinical Trial Manager, or Sr. Clinical Research Associate, the CRA/Monitor contributes to the tactical implementation and conduct of clinical research studies with specific responsibilities of monitoring the study. The CRA ensures the quality of each research study through remote monitoring of protocol and regulatory compliance. The CRA represents the company at the research site level and maintains collaborative relationships with investigator sites. The focus of the current research project is enrolling participants at clinical sites across the U.S who have recently been diagnosed with one of 20 types of cancer.
• Conducts remote interim monitoring visits per SOPs, Monitoring Plan and other guidance documents to ensure data integrity and good clinical practice; writes and submits visit reports
• Works together with study lead to review centralized monitoring tasks (remote data review for identification of queries, data trends, deviations, issue escalation, etc.)
• Tracks and escalates any safety events • Identifies need for CAPA/intervention plans
• Communicates site conduct and adherence to protocol directly to Sr. CRA or CTM as needed and through monitoring visits reports
• Reviews trial master files for missing and required documents
• Maintains professional relationship with clinical study sites
• Works independently with oversight from Sr. CRA or CTM or other study team members
• Works collaboratively with other clinical team members and cross functional teams as needed.
Minimum of 3+ years of clinical research experience as a CRA, clinical research coordinator, or combination of the two, with specific experience in monitoring in diagnostics, pharmaceutical, medical device, or CRO setting. Experience in cancer research is preferred but not required.
• Knowledge of medical terminology, clinical monitoring procedures (SOPs), and ICH/GCP guidelines • Ability to demonstrate attention to detail and accuracy in work
• Ability to demonstrate critical thinking skills
• Excellent written and oral communication skills
• Excellent organizational and time management skills
• Strong computer skills including Microsoft Office, EDC systems, eTMF
Bachelor' s degree: RN/BS/BA; scientific discipline preferred. Current GCP and HSR certification.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
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