Clinical Operations Specialist in San Francisco, CA at Apex Life Sciences

Date Posted: 5/29/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
    Other
  • Experience:
    Not Specified
  • Date Posted:
    5/29/2018
  • Job ID:
    853374

Job Description


CORE RESPONSIBILITIES:

  • 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. 
  • Carefully manage biospecimen accountability, chain of custody and quality. 
  • 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. 
  • Follow up and resolve discrepancies through communication with study team, Provide regular reports and summaries of biospecimen tracking activity. 

KNOWLEDGE/SKILLS/ABILITIES (KSA's): 

  • 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.

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