Clinical Study Laboratory Coordinator

Guidehouse•Bethesda, MD

6d•$65,000 - $108,000•Onsite

About The Position

We are currently searching for a Clinical Study Laboratory Coordinator to provide support to the National Institutes of Health (NIH). Successful candidates will be organized self-starters with strong project coordination skills. This is a full-time, on-site opportunity based in Bethesda, MD.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.

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