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.

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.

• Minimum of an Associate degree in a science related field.
• Knowledge of national and international specimen shipping regulations and biohazard requirements.
• Minimum of 2 years of relevant work experience in pharmaceutical, hospital, or medical research.
• 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.

• 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.

Reports to Safety laboratory Pre Analytical 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).

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

Work…