Laboratory Specimen Shipping and Processing Coordinator

What You Will Achieve

• The Laboratory Specimen Shipping and Processing Coordinator will collaborate with Lab Project Coordinators, Study Project Managers, and Safety Lab staff to coordinate the end-to-end processing, packaging, labeling, shipping, tracking, and confirmation of clinical research samples to internal and external partner laboratories in full compliance with DOT/IATA regulations and company policies.

• Maintain proper inventory of items necessary to support the shipping, processing and storage of clinical trial samples.

• Enter send out results as performed.

• Provides novel approaches to resolving problems and issues that may arise within the Safety or Biomarker Laboratories during assay conduct.

• May perform CLIA waived laboratory testing after appropriate training and skill sets have been demonstrated.

How You Will Achieve It

• Ensure all samples are packed for shipment in compliance with DOT and IATA regulatory agencies and company policies and procedures. Coordinate laboratory shipments with all customers, internal and external. Assures that planning and decision-making positively impact conduct of studies at the PCRU.

• Organize samples within storage units

• Ensure all appropriate staff perform DOT and IATA training.

• Utilize PIMS, Cerner and/or electronic notebooks for shipping and processing samples.

• Assists the Laboratory Managers with the Laboratory Quality and Improvement Plan by monitoring and reporting quarterly shipments and identifying pertinent quality goals for measuring and monitoring quality.

• Support sample processing and verification of specimen compliance as needed. Investigate any sample integrity and noncompliance issues and bring to the attention of Laboratory managers to ensure that it is rectified.

• Assist the Laboratory Quality Manager with preparation for Internal audits and CLIA, COLA or CAP audits.

• Monitor emails and voicemail to respond in an appropriate time frame.

• Maintain schedule flexibility to accommodate nonstandard patient visit, check-in, and discharge times.

• Work collaboratively and maintain open communication with Safety Lab and other PCRU departmental staff.

• Apply critical problem solving and effective decision making to resolve complex laboratory based problems that arise during study protocols.

QUALIFICATIONS / SKILLS

BASIC QUALIFICATIONS

• Minimum of a High School Diploma or Associate degree in a science related field with 2+ years of relevant work experience in pharmaceutical, hospital, or medical research.

• Knowledge of national and international specimen shipping regulations and biohazard requirements.
• Working knowledge of GxP, GCP, CAP, and CLIA/COLA regulations.

• Working knowledge of computers and laboratory data handling acquisition systems and associated issues/risks.

• Working knowledge of Word applications.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.
• Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.

PREFERRED QUALIFICATIONS

• Bachelor’s degree in a science related field

• Certification training in specimen shipping regulations.

• Understanding and demonstrated proficiency in handling laboratory projects.

• Knowledge of a pharmaceutical clinical research unit environment.

• Demonstrates teamwork by effective participation in multifunctional teams, motivate colleagues, build relationships with customers, and finding opportunities for collaboration.

ORGANIZATIONAL RELATIONSHIPS

Reports to Safety laboratory PreAnalytical Operations Manager, PCRU New Haven. Matrixed relationship with relevant PCRU study team members (lab project coordinators, clinical project managers, clinical coordinators, Biomarker assay Scientists, shift leaders, medical providers, and potentially study teams in Brussels, Belgium).

RESOURCES MANAGED

No direct reports. May manage contingent specimen processing staff. May direct specimen processors in absence of Lab Managers.

Additional Information:

• Work Location Assignment: On Premise

The salary for this position ranges from $26.86 to $44.77 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company’s policies. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. …