Clinical Study Laboratory Coordinator

What You Will Do

• Serve as the primary interface between Principal Investigators, Study Protocol Navigators, and the laboratory for in-house and reference laboratory testing related to clinical studies.
• Coordinate study-related testing workflows with Senior Staff, the Chief Technologist, Team Leads, LIS administrators, and the send-out team.
• Track and troubleshoot study specimen issues, including questions related to specimen collection, labeling, routing, acceptability, processing, send-out requirements, and resulting workflows.
• Coordinate follow-up when study specimens are not processed correctly, when workflow problems arise, or when protocol-specific laboratory procedures require revision.
• Assist with development, implementation, and maintenance of study-specific procedures for specimen handling, processing, shipment, and reporting for both in-house and send-out testing.
• Help coordinate new study test requests, including communication with LIS/build teams, reference laboratories, send-out operations, and section bench leads.
• Work with subject matter experts (Team Leads and Senior Staff) to implement SOP, workflow, and test-orders for study-related laboratory processes.
• Maintain tracking systems and documentation for study specimens, protocol-specific workflows, pending issues, and follow-up items.
• Facilitate communication of study-related testing issues and urgent workflow concerns to the appropriate laboratory personnel and clinical or study protocol teams.
• Assist with packing and shipping specimens to reference laboratories, as applicable, in accordance with laboratory and regulatory requirements.
• Escalate technical, medical, and policy questions to the appropriate Team Leads and Senior Staff and help coordinate implementation of the final plan.

What You Will Need

• Bachelor’s degree in a STEM field.
• Minimum of two (2) years of experience working with clinical specimens or in a clinical laboratory environment.
• Ability to manage multiple concurrent workflows and stakeholders.
• Proficiency in Microsoft Office Suite.
• Must be able to obtain and maintain a Federal or DoD "public trust"; candidates must receive approved adjudication prior to onboarding with Guidehouse. Candidates with an active public trust or suitability are preferred.

What Would Be Nice To Have

• Experience supporting clinical trials, study protocols, or research specimen workflows.
• Excellent communication, organizational, analytical, and time-management skills.
• Experience in clinical microbiology and molecular diagnostics preferred.
• Familiarity with laboratory information systems and/or test build workflows.
• Experience with specimen shipping and reference laboratory send-out processes.
• Ability to lift 10–30 pounds.

Pay

The annual salary range for this position is $65,000.00–$108,000.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs.

Benefits

• Medical, Rx, Dental & Vision Insurance
• Personal and Family Sick Time & Company Paid Holidays
• Parental Leave
• 401(k) Retirement Plan
• Group Term Life and Travel Assistance
• Voluntary Life and AD&D Insurance
• Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts
• Transit and Parking Commuter Benefits
• Short-Term & Long-Term Disability
• Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities
• Employee Referral Program
• Corporate Sponsored Events & Community Outreach
• Care.com annual membership
• Employee Assistance Program
• Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)
• Position may be eligible for a discretionary variable incentive bonus

This response is AI-generated, for reference only.