Clinical Operations Specialist
San Francisco Metro Area, CA
1) biospecimens from sites to central lab to third party labs; and
2) biospecimens from sites directly to third party labs. The candidate should have experience in cross-checking and resolving biospecimen attributes between EDC/IVR and vendor databases, commonly referred to as header reconciliation.
This individual will be primarily responsible for tracking a complex array of biospecimens for high profile clinical trials in clinical pharmacology, hematology/oncology, inflammation/immunology or immuno-oncology.
1. Carefully manage biospecimen accountability, chain of custody and quality.
2. Utilize software tools such as Labmatrix or related biospecimen management system to track biospecimens, identify discrepancies, verify and document consent and ensure compliant utilization of biospecimens by following written procedures.
3. Follow up and resolve discrepancies through communication with study team, sites or CROs/vendors within specified timeframes.
4. Provide regular reports and summaries of biospecimen tracking activity.
Bachelor s Degree preferably in the life sciences with 2-4 years clinical trial biospecimen management experience in a clinical/diagnostic laboratory or pharmaceutical/biotechnology R&D environment.
Ability to follow good clinical practices (GCP), standard operating procedures (SOPs) and working procedures (WPs).
Demonstrated understanding of basic principles in clinical research and biospecimen processing procedures involving blood and tumor biopsies.
Experience in working with clinical trial protocols and informed consent.
Detailed knowledge and experience in case report forms, EDC listings, central laboratories databases and query resolution
Awareness of global biobanking issues; basic experience in working in organizations adhering to quality standards.
Experience with Labmatrix, GSS or related sample management system is a plus.
Knowledge of at least one data management system experience with SAS data sets and conversion procedures is a plus.
Knowledge of MS Office program suite required.
Intermediate-level Excel is a plus.
Professional inter-personal skills and excellent oral/written communication.
Leadership skills in conflict management, facilitation and negotiation a plus.