Clinical Lab Assistant
Franklin Lakes, NJ US
This is a laboratory-based position for Integrated Diagnostic Solutions (IDS), Specimen Management Clinical Lab business unit. This position has specific assignments to evaluate, execute and report on the safety and efficacy of new or modified in-vitro diagnostic devices. They will possess technical competence in phlebotomy and sample processing for the clinical laboratory. The phlebotomist will recruit subjects for clinical studies and perform blood collections, prepare specimens for laboratory testing as well as perform screening procedures according to specific protocol procedure requirements. They will possess technical competence in performing laboratory pre- and post-analytic phases of sample processing (preparing samples/ specimens). Maintain cleanliness and upkeep of all laboratory spaces according to laboratory safety protocols and procedures. Responsible for understanding product design and function and applying quality and regulatory standards. Utilize technical/scientific judgement to resolve technical issues. Works with many different disciplines (manufacturing, marketing, quality, regulatory, etc.), materials, products, and processes in the development and monitoring of acquisition and containment products. Possesses a strong commitment to quality and continuous improvement.
PRIMARY DUTIES, RESPONSIBILITIES & AUTHORITIES:
Formulates and conducts scientific investigations in areas of considerable scope and complexity. Explores, identifies, and recommends solutions, concepts and principles.
- Collects specimens from volunteers for utilization in laboratory testing and in a manner, which ensures safety by following OSHA regulation, and preserves the confidentiality of the participants.
- Verifies subject availability and suitability for clinical studies according to the Associate Sample Collection Program (ASCP) and study protocol requirements.
- Verifies subject identification.
- Maintains specimen integrity by using aseptic technique, following department Standard Operating Procedures (SOP).
- Tracks collected specimens by initialing, dating, and noting times of collection;maintaining daily metrics of lab activities performed
- Maintains quality results by following study protocol procedures and testing schedule;recording all pertinent information required during processing procedures. Follow methodologies in carrying routine tasks.
- Perform laboratory processing including pre- and post-analytic phases of samples/specimens
- Produce accurate and reliable data
- Research relevant topics and gather information/data
- Adhere to correct procedures, policies and health/safety guidelines
- Keep abreast of all industry developments and best practices
- Document all activities, record results and insert/retrieve data
- Maintain work area and equipment with upkeep of all lab spaces, cleaning all lab surfaces, and maintaining organization.
- Receive, unpack and correctly store all lab deliveries
- Maintain records for refrigerator/freezer temperatures
- Provide administrative assistance
- Maintains safe, secure, and healthy work environment by following standards and procedures, complying with IRB and other regulatory procedures.
- Updates job knowledge by participating in educational opportunities;reading professional publications;maintaining personal networks;participating in professional organizations.
- Enhances the clinical lab processing areas by accepting ownership for accomplishing new and different requests, exploring opportunities to add value to job accomplishments.
- Interfaces with R&D, Marketing, Manufacturing, Corporate Statistics, QA and Regulatory to insure the successful and timely completion of projects.
- Provides technical support to worldwide functions, Manufacturing, Marketing and other divisions as needed in the areas of training and product evaluation.
Actively supports departmental, divisional and company policies and procedures. Maintains the proprietary and confidentiality interests of the company.
KNOWLEDGE AND SKILLS:
5-10 years minimum phlebotomy experience in hospital or regulated clinical setting
Good reading, writing, and communication skills
Proficient in use of Outlook and Microsoft Teams
Proficient in Microsoft Word and Excel
EDUCATION AND EXPERIENCE:
High School Diploma or GED
Accredited Phlebotomy Program
LICENSES OR CERTIFICATIONS:
Certified Phlebotomy Technician (CPT)
National Health-career Association (NHA) or the National Phlebotomy Technician Certification Exam from the National Center for Competency Testing (NCCT).
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.