Laboratory Technician & Specimen Shipping Specialist
- As Clinical Research Sample Shipping Specialist s/he will work closely with the Study Project Manager and Primary Study Lead to coordinate the transportation of sample to other laboratories during the execution of internal and external clinical research studies.
- Responsible for coordinating proper packaging and labeling of sample shipments according to the DOT and IATA regulations and company policies and procedures. Track and confirm all shipments as per company policy and procedures.
- Responsible for the DOT and IATA training of appropriate staff.
- Provides novel approaches to resolving problems and issues that may arise with sample processing or sample shipment within the Safety or Biomarker Laboratories during assay conduct.
- Leads and/or supports metrology requirements.
- May perform CLIA waived laboratory testing after appropriate training and skill sets have been demonstrated.
- Responsible and accountable for accurate and timely national and/or international shipping of all NHPCRU samples.
- Ensure all samples are packed for shipment in compliance with DOT and IATA regulatory agencies and company policy and procedures.
- Maintain credential and certification for shipping of biohazardous materials nationally (DOT) and internationally (IATA).
- Responsible for training and mentoring personnel in sample management and shipping procedures as assigned.
- Ensure that staff DOT and IATA training is current.
- Utilize PIMS, Cerner and/or electronic notebooks for processing samples.
- Organize and monitor samples within storage units.
- Monitor temperature sensitive equipment, record deviations, and provide corrective actions for temperature/humidity deviations.
- After appropriate training CLIA waived immunological tests according to the Standard Operating Procedures.
- Perform all quality control checks on instruments, reagents, and techniques, maintain quality control and calibration data.
- Prepare and check reagents and supplies. Perform calculations for work solutions or other calculations as required during experimental procedures.
- Perform and document required routine maintenance and calibration of laboratory instruments.
- Maintain the inventory of and order laboratory supplies including notifying instrument key operators of upcoming reagent/supply needs.
- Process samples for analysis or storage. Utilize PIMS/LIMS computer system for the processing of samples.
- Maintain clean and safe work areas per SOP.
- Write new or revise procedures for the SOP or Manuals as assigned.
- Arrange for purified water testing to be performed as needed and alert Lab Coordinator or Designee
- Assist the Laboratory Quality Coordinator with preparation for Internal audits and CLIA, COLA or CAP audits.
- Will perform continuing education as assigned
- Will cover off hours PK sample processing as needed.
- Will cover Specimen Processor functions as needed.
- Will do EQA (external quality assessment)/ proficiency sample testing as assigned for waived testing
- Will bring any issue of noncompliance to the attention of Lab Quality Coordinator or the Lab Manager and act to rectify the situation.
- Be flexible with the schedule to cover inadvertent times that subjects/volunteers arrive for visits, check-ins, and discharges late.
- Be able to function autonomously.
- Perform critical problem solving
- Resolves laboratory-based problems that occur in study protocols regarding specimen processing or integrity. Has effective decision-making abilities that allows developing new options for moderately complex problems.
- Minimum of an Associate degree.
- Knowledge of national and international specimen shipping regulations and biohazard requirements.
- Minimum of 3 years of relevant work experience in pharmaceutical, hospital, or medical research.
- Knowledge of clinical trials a plus.
- Working knowledge of GxP, GCP, CAP, and CLIA 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.
Demonstrates teamwork by effective participation in multifunctional teams, motivate colleagues, build relationships with customers, and finding opportunities for collaboration.
Being able to pack and pick up moderate size boxes.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Other Job Details:
- Eligible for Relocation Package: NO
- Eligible for Employee Referral Bonus: YES