Spec 2, Clinical Operations, Clinical Research Associate

Planet Pharma Group; Franklin Lakes (NJ); On-site; USD 39,000 - 47,000; Full time

Job summary

Planet Pharma is seeking a skilled phlebotomist for a laboratory-based Specimen Management role in the Clinical Lab business unit. The position focuses on evaluating, executing, and reporting on the safety and efficacy of in‑vitro diagnostic devices.

You will recruit subjects, perform blood collections, prepare specimens, and adhere to quality and regulatory standards. Responsibilities include venipuncture and fingerstick collections, maintaining specimen integrity, and documenting processing

Qualifications

• High School Diploma or GED is required.
• Accredited Phlebotomy Program completion is required.

Responsibilities

• Formulates and conducts scientific investigations in areas of considerable scope and complexity.
• Collects blood from volunteers for laboratory testing following OSHA regulations and protects participant confidentiality.
• Verifies subject availability and suitability for clinical studies per protocol requirements.
• Obtains blood specimens by venipuncture and fingerstick collections.
• Maintains specimen integrity using aseptic technique and SOPs.

Skills

Phlebotomy experience

Communication skills

Outlook

Microsoft Teams

Word & Excel

Education

High School Diploma or GED

Accredited Phlebotomy Program

Tools

Outlook

Microsoft Teams

Microsoft Word

Excel

Job description

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

• 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).

Pay Range

28-34/hr *based on experience