PK Lab Technician
evolution research groupMiami (FL)
About the role
Lab Assistant The Lab Assistant will perform basic and complex clinical and pharmacokinetic specimen collection and processing (upon assignment) for Phase 1 clinical trials, primarily healthy paid volunteers. Duties will primarily focus on assisting the Lab Manager in processing laboratory samples but will also include clerical and data entry duties. Hours are project dependent and sometimes require weekends and/or very early or late hours.
Responsibilities:
- Monitor urine collection temperatures, as assigned.
- Monitor 24-hour specimen collections (i.e., urine, feces), as assigned.
- Maintain sample collection area clean and stocked with all necessary supplies.
- Notify appropriate staff of abnormal results while collecting specimens, adverse events, or unusual incidents.
- Act as courier to Pharmacokinetic laboratory for collected specimens.
- Assure minimal discomfort for study participants while performing all duties.
- Maintain safety and well-being of study participants during assigned shift.
- Safety lab requisition creation and sample send out to the local labs.
- Labeling of PK/PD collection tubes
- Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG's objectives.
Skills and Qualifications:
- Certification as a Phlebotomy Technician and/or a minimum of six months experience working as a phlebotomist at a medical facility.
- Clinical Research experience preferred but not required.
- BLS and/or ACLS certification preferred but not required.
- Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
- Knowledgeable in medical terminology
- Excellent communication skills (interpersonal, written, verbal)
- Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)
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