Laboratory Technician

A Laboratory Technician is assigned lab work that is performed effectively and efficiently on a daily basis; monitors all laboratory logs and other relevant documentation; has an understanding of laboratory practices as they relate to the clinical research process, FDA regulations, Good Clinical Practices, OSHA guidelines and regulations, Institutional Review Board (IRB) regulations and sponsor commitment.

Essential Job Functions:

  • Assists in conducting research protocols in a manner that ensures quality, consistency, timelines, accuracy and subject safety
  • Must be thoroughly familiar with the protocol, informed consent, source documentation, subject diary (when applicable), and study medications(s) for the assigned research study
  • Develops knowledge of FDA regulations regarding “Good Clinical Practices” and applies it during conduct of the clinical trial
  • Establishes rapport with subjects, relatives/friends of subjects, doctors, office/hospital staff and any other personnel involved in the conduct of the study
  • Performs protocol procedures as delegated by the Principal Investigator which may include, but are not limited to the following: vital signs, pregnancy tests, blood collection, ECG collection, urine collection, alcohol breath tests and pain assessments
  • Completes precise and timely progress notes (source documents) for study subjects as needed
  • Performs basic lab procedures, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-ups (when applicable)
  • Assists with maintenance of adequate inventory of supplies needed to complete each study
  • Maintains logs including chain of custody logs, temperature logs, protocol and subject specific logs as appropriate
  • Ensures ongoing maintenance of laboratory records and quality control logs of equipment
  • Follows GCP guidelines and OSHA regulations and guidelines
  • Assists with ensuring that study specific lab supplies are on site prior to study start and replenished during study conduction as needed
  • Assists with ensuring that equipment is operating to sponsor, vendor, and protocol specifications
  • Assists with ensuring that laboratory equipment is current on all maintenance and calibration
  • Resolves laboratory queries as necessary
  • Other duties as assigned

Knowledge, Education, and Experience:

  • High School diploma – clinical research experience preferred
  • Medical Assistant certification or relevant education/experience preferred
  • CPR and Phlebotomy certification (national) preferred
  • Maintain continuing education via conferences, seminars and workshops

 

Job Category: Clinical

Job Type: Full Time

Job Location: BerlinMarlton

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