- BeiGene (Emeryville, CA)
- …in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the ... Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing **Quality:** + Handles escalated issues...GCP and all other relevant regulations + Ensures inspection readiness for study in region at any point… more
- BeiGene (Emeryville, CA)
- …study sites to ensure data quality and patient safety in accordance with ICH- GCP guidelines, local regulations, and applicable SOPs. The SCRA collaborates with the ... study-specific monitoring issues * Provide direct support to the Clinical Study Manager by assisting with monitoring visit report review and other managerial tasks… more
- Abbott (Alameda, CA)
- …of multiple clinical trials according to the Code of Federal Regulations, ICH GCP , and ISO14155. This is an on-site position in Alameda, California. This is ... sites. + Perform study device accountability and reconciliation. + Assist senior staff in development of study-specific forms and trial-specific monitoring plans.… more
- Abbott (Alameda, CA)
- …of multiple clinical trials according to the Code of Federal Regulations, ICH GCP , and ISO14155. **What You'll Work On** the below mentioned responsibilities as ... to clinical sites. *Perform study device accountability and reconciliation. *Assist senior staff in development of study-specific forms and trial-specific monitoring… more
- Abbott (Alameda, CA)
- …department procedures and applicable regulatory requirements. + Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), ... + Maintain and audit Trial Master File to ensure inspection readiness. + Perform review of clinical data listings...and accuracy, and escalate issues to the Clinical Operations Manager as needed. + Participate in cross-functional clinical team(s)… more