Clinical Laboratory Scientist

Job purpose

The Clinical Laboratory Scientist is responsible for supervising clinical laboratory operations. The Clinical Laboratory Scientist will use their expertise to support clinical trials, product development, and manufacturing operations activities.

Duties and responsibilities

· Supervise operations in the CLIA certified second tier testing newborn screening laboratory, including coordinating send-out activities and accurate delivery of patient results.

· Deliver patient laboratory results within specified TAT

· Maintain compliance with CLIA, HIPAA, company policies, and other regulations, including identification and investigation of problems that may adversely affect test performance or reporting and correct according to established procedures.

· Capture and trend relevant laboratory metrics for presentation to management.

· Support R&D, product development and manufacturing operations activities, including performing molecular/biochemical testing using either Baebies’ platforms or other laboratory equipment.

· Assist Regulatory and Clinical Affairs team with preparation of clinical protocols, informed consent, clinical study reports, and other required documents for clinical studies.

.

Requirements:

Qualifications

Minimum Bachelor’s Degree in science related field, or equivalent.

Medical Technology background preferred.

• Must meet CLIA General Supervisor qualifications
• A minimum of 2 years of experience as a Technologist in a clinical laboratory
• Strong working knowledge of CLIA, CAP and relevant state regulations
• Understanding of laboratory operations as well as policies and procedures
• Strong communication skills, both written and verbal
• High level of attention to detail with strong organizational skills
• Comfort making decisions in a changing environment

Preferred Requirements:

• ASCP and/or AMT certifications are a plus
• Molecular experience, including real-time PCR and NGS is preferred
• Clinical Trial experience preferred

Physical requirements

• This position is very active and requires regular standing, walking, reaching, and sitting. Specific vision abilities required by this job include close vision, distance vision, color vision to detect color-changes in testing and labeling, peripheral vision, depth perception, and ability to adjust focus.