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Bio specimen Management
Ref No.: 18-15400
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 Biospecimen Management in San Francisco, CA with one of our top client.
Job Title:
Biospecimen Management
Job Id: 18-15400
Location: San Francisco, CA 94158
Duration: 12 months
Position Type: Hourly contract Position (W2 only)
 
Summary
  • The is a role in end-to-end bio specimen management for clinical trials.
  • Candidates Managed bio specimens for clinical trials.
  • Previously worked with clinical study teams in clinical trial study start-up.
  • Proven past experience in working on clinical trial protocols, ICFs, eCRFs.
  • Experience executing on a biomarker sampling plans for clinical trials
  • Working with central labs in study start-up i.e. SOW experience and managing/tracking bio specimens during a trial 
Core Responsibilities
  • The primary responsibilities of the BSO Contractor are to support TD and clinical teams in the implementation and maintenance of bio specimen management strategies for often complex, global clinical studies in each of the following areas under minimal supervision:
  • Bio specimen 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 bio specimen-related/site issues and implement viable solutions in a timely manner.
  • Play a key role in planning and designing clinical trial and bio specimen operations support internally and externally. 
Bio specimen management
  • Utilize software tools to track bio specimens, identify discrepancies, verify and document consent, and ensure compliant utilization of bio specimens by following written procedures.
  • Maintain regular metrics of bio specimen activities for studies that he/she supports.
  • Follow up and resolve discrepancies through communication with study team, sites, or CROs/vendors within specified timeframes.
  • Clinical study teams
  • Plan/design bio specimen handling logistics and review biomarker-related clinical documents clinical protocols, ICFs, CRFs for successful study start-up.
  • Create and maintain bio specimen laboratory manuals and provide hands-on bio specimen processing training at clinical sites.
  • Support clinical and/or CRO to review supporting bio specimen documentation, labels, requisition forms and manifests to ensure documented sample chain-of-custody and the rapid reconciliation of bio specimens. 
CROs and Vendors
  • Work with manager and clinical development teams to plan/design bio specimen 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. 
Knowledge/Skills/Abilities (Ksa's)
  • In addition to above listed, the incumbent should have proficient skills in each of the following areas and have demonstrated application in the context of clinical trials and bio specimen management. 
Clinical Trials
  • Proficient knowledge of FDA regulatory requirements and GCP; have a demonstrated, intuitive understanding of clinical trials. 
Scientific/Laboratory Skills
  • Proficient knowledge of relevant therapeutic and technical areas; demonstrated understanding of laboratory techniques in the life sciences; demonstrated understanding of principles in clinical research and clinical procedures involving blood/biopsy collection, handling and processing.  
Bio banking
  • Understanding of global bio banking issues; proficient experience working in organizations adhering to quality standards and working with regulations pertaining to general bio specimen transportation requirements. 
Drug Development
  • Proficient understanding of the drug development process.
  • Professional inter-personal skills and excellent oral/written communication.
  • Experienced in presenting logistics and processing instructions, including basic scientific and clinical content, to internal and external audiences.
  • Basic leadership skills in conflict management, facilitation and negotiation.
  • Proficient computer skills in Microsoft Office.
  • Experience with databases and intermediate-level Excel a plus.
  • Up to 20% travel to clinical sites to train sites on bio specimen procedures. 
Contact
Sourabh Agrawal | Lead - Talent Acquisition
Direct: (732) 272 0301| Email: sourabh@sunrisesys.com