Title: Biospecimen/ Sample Management Associate

Location: Menlo Park, CA

Forty Seven Inc. is committed to helping patients defeat their cancer. We are advancing immune-oncology through the engagement of new and complementary phagocytic pathways that enhance anti-tumor efficacy and selectivity.

 

Summary:

The primary function of this role is to support the Sample Management department in the execution and oversight of biospecimen management for clinical trials conducted by Forty Seven.  We are seeking a motivated, dynamic, team-oriented individual with a vision and passion for establishing and operating efficient biospecimen management activities.  This position will be part of the biospecimen management team and work closely with cross-functional teams in Clinical, Translational, Clinical Pharmacology, Biometrics, Data Management, and Clinical Operations and report into the Biological Sample Management, Manager.

 

Essential Functions:

These may include, but are not limited to, the following; other duties may be assigned

  • Support senior members of the sample management department in project activities to meet study milestones and timelines
  • Help ensure that biospecimen samples are managed, stored (includes long-term inventory of samples), and disposed of consistent with the clinical protocol, with the patient informed consent, and with regulatory and biohazard guidelines, and with international transport guidelines, if applicable.
  • Trigger the shipment of samples to their appropriate testing/assay lab and reconcile any issues from that transfer
  • Review of clinical protocols, subject informed consent forms, training documents, and other relevant study-related documents to ensure alignment and compliance with biospecimen management requirements
  • Schedule meetings and assist in minutes capture for Sample Management
  • Aid in TMF document filing and review of TMF to ensure completeness
  • Ensure robust processes for maintaining chain of custody and compliance with GCP/GLP requirements for biospecimen collection
  • Assist in the authoring and review of SOPs for Sample Management
  • Aid in the development study-specific biospecimen analysis plans (including specimen collection schedule and collection, handling, shipping and storage requirements) that align with the clinical protocol and stakeholder needs
  • Work with clinical study teams and central laboratory(ies) to develop study-specific guidelines and procedures for sample collection kit development, sample collection and handling, transport, storage, sample processing, testing, test result reporting, data aggregation, and sample destruction
  • Help develop and present training guidelines and materials for clinical sites and internal study teams
  • Ensure effective and efficient processes for biospecimen management including sample tracking and data reconciliation and discrepancy resolution
  • Interact with central lab(s) responsible for biospecimen handling and storage (e.g., sample collection kit production, receiving, processing and storage)
  • Identify, communicate and problem solve relevant issues related to biospecimen management that present potential risk to study compliance, timelines or analyses
  • Contribute to department process improvement by identifying areas for efficiency and improvement and developing/reviewing SOPs and processes as needed

 

Education & Experience:

  • Bachelor's degree in science or health-related field required
  • 2+ years in Pharmaceutical or Biotech company, with at least 1 year in clinical biospecimen management and oversight for clinical trials
  • Prior experience in oncology and/or early phase, complex clinical trials preferred
  • Thorough and proven knowledge of applicable GCP, GLP, CFR and ICH guidelines
  • Ability and knowledge to work effectively with multiple stakeholders (clinical, translational research, clinical pharmacology and clinical operations)
  • Exceptional interpersonal skills, team-oriented approach, collaborative with ability to provide leadership and guidance to growing team/function\
  • Must have excellent written and verbal communication skills with ability to be diplomatic and professional in all situations
  • Strong interpersonal, project management and organizational skills; able to prioritize and work effectively in a fast paced environment
  • Working knowledge of MS Word, Excel and Adobe Acrobat; experience with LIMS and/or other lab management databases
  • Strong working knowledge of GCP/ICH regulations and guidelines as relates to biospecimen management

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