Clinical Biospecimen Ops Assoc

Position Summary

The Clinical Biospecimen Operations Associate executes clinical research studies, including coordination of all operational activities required for tracking, testing, and reporting clinical trial samples. This position works under the oversight of the Manager, Sample Management, and collaborates closely with internal and external central testing laboratories, Clinical Trial Services Study Lead, Data Management, Product Management, Engineering, and external collaborators. All tasks are performed in compliance with the study protocol(s), SOPs, and applicable regulatory requirements.

Primary Responsibilities

• Routine Sample Management: Maintain oversight of study sample management activities, including tracking and testing clinical trial samples to ensure results are provided within contractual turnaround times (TAT).

  • Meticulously track samples from receipt to result reporting and, if applicable, sample return.

  • Escalate cases with no movement in lab processing or logistical issues to the Study or Clinical Trial Services (CTS) Lead as appropriate.

• Issue Resolution:

  • Escalate sample management issues halting production to the appropriate stakeholders, such as study leads, tissue testing vendors, or other cross-functional representatives.

  • Monitor incomplete specimen sets and resolve aging cases beyond acceptable thresholds with Study Lead and Sponsor.

  • Facilitate residual specimen returns to sites.

• Monitoring and Reporting:

  • Prepare and maintain documentation for remote or onsite audits and monitoring visits.

  • Contribute to sample management dashboards and tools by monitoring and reporting on sample management KPIs.

  • Collaborate with Data Management and other teams to develop and maintain dashboards and metrics related to clinical trial sample testing and present them as needed.

• Collaboration and Communication:

  • Support coordination with Natera WES vendor testing liaisons.

  • Lead sample management meetings, including agenda preparation and taking minutes.

  • Work with internal teams to address operational challenges and ensure deliverables and TAT are met.

• General Duties:

  • Perform tasks of moderate scope and complexity with guidance from the manager or senior peers.

  • Build solid working relationships within the Clinical Trial Operations organization.

  • Identify and suggest process improvements as development opportunities.

  • Maintain current training requirements, including General Policies and Procedure Compliance and security training.

  • Perform other duties as assigned.

Qualifications

• Education: BA/BS degree in life sciences, related field, or equivalent.

• Experience: Minimum of 2 years of experience working on clinical studies in academic, biopharma, diagnostics, or medical device fields. Previous relevant job experience preferred.

• Background Check: Must pass a post-offer criminal background check.

Knowledge, Skills, and Abilities

• Familiarity with biospecimen management, sample processing, and biobanking best practices.

• Experience with clinical Electronic Data Capture (EDC) systems.

• Knowledge of the Trial Master File (TMF) structure and organization.

• Competency in SOPs, ICH-GCP, and FDA regulations.

• Proficiency in MS Word, Excel, and PowerPoint.

• Strong analytical skills with the ability to identify and resolve issues.

• Detail-oriented with solid organizational and time management skills.

• Demonstrated ability to work independently with an outgoing and confident demeanor.

• Ability to utilize operational and project management skills to meet deliverables and TAT.

• Commitment to maintaining compliance with HIPAA/PHI privacy, human subjects protection, and GCP training requirements.

Physical Demands and Work Environment

• Frequent sitting, standing, and walking.

• Daily use of a computer is required.

• May need to stand for extended periods during meetings or while walking in the facilities.

• Reasonable accommodations may be made for individuals with disabilities to perform essential job functions.