Clinical Operations Specialist

Job Title: Biological Sample Management Associate – Translational Medicine

Location: Santa Monica, CA

Duration:12+ month contract

Pay rate:$40- $43.30/hr.

Description:

We are seeking a Biological Sample Management Associate to join our Translational Medicine team. This role focuses on biospecimen sample management across multiple clinical trials and programs, ensuring accurate tracking, processing, and delivery of biological samples for pharmacokinetic, pharmacodynamic, safety, and exploratory analyses. The individual will report to Associate Director of Project Management in Translational Medicine and collaborate closely with Clinical Operations, Biometrics, and Data Management teams.

Key Responsibilities

• Primary focus on biological sample management for several clinical trials within and across development programs.

• Track and reconcile sample collection, processing, and shipment activities; resolve sample-related issues in collaboration with Clinical Operations.

• Maintain and update laboratory processing instructions and ensure consistency across programs.

• Navigate central laboratory sample management systems and Kite’s Clinical Pharmacology Laboratory Information Management System (CPLIMS) to generate inventory reports and manage sample orders.

• Place sample requests in compliance with protocol and informed consent requirements, including optional biomarker analyses and subject consent tracking.

• Troubleshoot discrepancies in sample requests and coordinate resolution with internal teams and external specialty vendors.

• Support development and review of biomarker-related content in protocols, informed consent forms, and laboratory manuals.

• Assist with vendor management activities such as RFPs, budget reviews, and scope of work for laboratory services.

• Collaborate on timelines for sample analysis and data transfer to meet program deliverables.

• Perform quality control checks on laboratory data prior to analysis and assist with ad hoc sample analysis requests.

• Provide input into protocol deviation lists related to biomarker/sample handling.

• Address site and IRB/EC/IBC questions regarding sample management.

• Attend study team meetings and contribute to sample-related discussions.

• Light travel (approx. 10%) as needed.

Requirements

• Bachelor’s degree in biological sciences (preferred).

• 2–3 years of experience in biological sample management within clinical research or equivalent.

• Strong understanding of sample collection, processing protocols, and shipping conditions.

• Familiarity with Laboratory Information Management Systems (LIMS) and central lab systems (e.g., LabLink).

• Excellent organizational skills with ability to multitask and prioritize effectively.

• Detail-oriented, self-motivated, and able to work cross-functionally.

• Proficient in Microsoft Office and Excel.