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Bio specimen Tracking and Reconciliation (T&R)
Ref No.: 18-15399
Location: San Francisco, California
Position Type:Contract
Start Date / End Date: 10/29/2018 to 10/25/2019
Sunrise System Inc. is currently looking for Bio Specimen Tracking and Reconciliation (T&R) in San Francisco, CA with one of our top client.
Job Title: Bio specimen Tracking and Reconciliation (T&R)
Job Id: 18-15399
Location: San Francisco, CA 94158
Duration: 12 months
Position Type: Hourly contract Position (W2 only)
 
Desired Skills
  • Candidates for this position proven experience in tracking clinical trial bio specimens including
  • Bio specimens from sites to central lab to third party labs;
  • Bio specimens from sites directly to third party labs.
  • Experience in cross-checking and resolving bio specimen attributes between EDC/IVR and vendor databases, commonly referred to as header reconciliation. 
Core Responsibilities
  • This individual will be primarily responsible for tracking a complex array of bio specimens for high profile clinical trials in hematology/oncology.
  • Carefully manage bio specimen accountability, chain of custody and quality.
  • Utilize software tools such as Lab matrix or related bio specimen management system to track bio specimens, identify discrepancies, verify and document consent and ensure compliant utilization of bio specimens by following written procedures.
  • Follow up and resolve discrepancies through communication with study team, sites or CROs/vendors within specified timeframes.
  • Provide regular reports and summaries of bio specimen tracking activity.  
Knowledge/Skills/Abilities (Ksa's)
  • Bachelor’s Degree preferably in the life sciences with 2-4 years’ clinical trial bio specimen 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 bio specimen 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 bio banking issues; basic experience in working in organizations adhering to quality standards.
  • Experience with Lab matrix, 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.
Contact
Sourabh Agrawal | Lead - Talent Acquisition
Direct: (732) 272 0301| Email: sourabh@sunrisesys.com