This site uses cookies. To find out more, see our Cookies Policy

End to End (E2E) Biospecimen Management - CA in San Francisco, CA at Apex Life Sciences

Date Posted: 12/11/2018

Job Snapshot

Job Description


CORE RESPONSIBILITIES:

  • The primary responsibilities of the BSO Contractor are to support TD and clinical teams in the implementation and maintenance of biospecimen management strategies for often complex, global clinical studies in each of the following areas under minimal supervision: 
    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. 

KNOWLEDGE/SKILLS/ABILITIES:

  • The incumbent should have proficient skills in each of the following areas and have demonstrated application in the context of clinical trials and biospecimen 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. 
    • Biobanking:
      • Understanding of global biobanking issues; proficient experience working in organizations adhering to quality standards and working with regulations pertaining to general biospecimen 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 biospecimen procedures.

#LI-KH2

Please send resumes to khurlbut@apexlifesciences.com

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




903605