Spec 2, Clinical Operations, Clinical Research Associate

Pay rate: $35.00 on site. 9 panel drug test . Certification is required in phlebotomy This is a laboratory-based position for 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.

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

Formulates and conducts scientific investigations in areas of considerable scope and complexity.

Explores, identifies, and recommends solutions, concepts and principles.

Collects blood 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.

Obtains blood specimens by performing venipunctures and fingerstick collections.

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, removal of biohazard waste, 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.

Education And Experience

High School Diploma or GED

Accredited Phlebotomy Program

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

Licenses/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).