San Francisco Metro Area, CA
1. Biospecimen operations: Maintain knowledge/status of assigned clinical protocols and be able to follow good clinical practices (GCP), standard operating procedures (SOPs) and working procedures (WPs). Might be called upon to assist in the authorship of SOPs and WPs. Be able to handle, identify and resolve complex biospecimen-related/site issues and implement viable solutions in a timely manner. Play a key role in planning and designing clinical trial and biospecimen operations support internally and externally.
2.Biospecimen management: Utilize software tools to track biospecimens, identify discrepancies, verify and document consent, and ensure compliant utilization of biospecimens by following written procedures. Maintain regular metrics of biospecimen activities for studies that he/she supports. Follow up and resolve discrepancies through communication with study team, sites, or CROs/vendors within specified timeframes.
3.Clinical study teams: Plan/design biospecimen handling logistics and review biomarker-related clinical documents clinical protocols, ICFs, CRFs for successful study start-up. Create and maintain biospecimen laboratory manuals and provide hands-on biospecimen processing training at clinical sites. Support clinical and/or CRO to review supporting biospecimen documentation, labels, requisition forms and manifests to ensure documented sample chain-of-custody and the rapid reconciliation of biospecimens.
4. CROs and Vendors: Work with manager and clinical development teams to plan/design biospecimen handling logistics with preferred vendors on the manufacture of sample collection kits and execution of associated logistics; will be expected to take on a primary role in working with scientists and analytical laboratories on generating work order requests, work specifications and logistics.