Senior Clinical Laboratory Research Specialist - Contract

MillenniumSoft Inc; Franklin Lakes (NJ); On-site; USD 62,000 - 69,000; Part time

Job summary

Medical Devices Company in Franklin Lakes, NJ is seeking a Clinical Laboratory Research Specialist (min 5+ yrs in regulated industry) for a 12-month contract. Onsite role, 40 hours/week, 9-panel drug test, pay rate $45-$50/hr.

You will design, evaluate and report on safety and efficacy of in-vitro diagnostic devices, working across cross-functional teams. The role requires lab-based expertise across phlebotomy, chemistry, hematology, coagulation, urinalysis and POC testing.

Qualifications

• BS/BA/MA in Clinical Laboratory Science or Medical Technology, Biology/Life Sciences or health-related field.
• MT/MLT CLS (ASCP) or equivalent experience in a Research environment.
• 5+ years experience in the Clinical Laboratory environment.
• Familiarity with GCP/GLP and ISO regulations is preferred.

Responsibilities

• Input to design, evaluation, execution and reporting for safety and efficacy of IVD devices.
• Manage clinical laboratory studies and complaint testing across methods.
• Develop/testing methodologies in collaboration with R&D.
• Ensure adherence to quality/regulatory standards including CLSI guidelines.
• Train new associates on Laboratory workflow.
• Collaborate with manufacturing, quality, regulatory teams to advance projects.

Skills

Clinical lab science

Communication skills

Regulatory knowledge

Phlebotomy

Blood handling

Troubleshooting

Computer skills

Project budgeting

R&D collaboration

Clinical testing know-how

Education

Bachelor's degree in CLS or related

ASCP certification

5+ years CL lab experience

Job description

Medical Devices Company in Franklin Lakes, NJ is seeking a Clinical Laboratory Research Specialist (min 5+ yrs in regulated industry) for a 12-month contract. Onsite role, 40 hours/week, 9-panel drug test, pay rate $45-$50/hr.

You will design, evaluate and report on safety and efficacy of in-vitro diagnostic devices, working across cross-functional teams. The role requires lab-based expertise across phlebotomy, chemistry, hematology, coagulation, urinalysis and POC testing.