PK Lab Technician

We are seeking a Lab Technician will perform basic and complex clinical and pharmacokinetic specimen collection and processing (upon assignment) for Phase 1 clinical trials, primarily involving 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 shifts. Candidates must have a flexible schedule to accommodate patient scheduling needs.

Key Requirements:

• Experience in a clinical research lab setting (Phase 1 experience preferred).
• Ability to operate and manage specialized laboratory instrumentation.
• Willingness to be trained on company-provided equipment and follow protocol-specific processing requirements.
• Comfortable with PK sample processing, QC, and lab workflows beyond basic collection/handling.

The company is prioritizing candidates who can step into a technical, hands-on lab role, not just sample processing support.

Responsibilities:

• Monitors urine collection temperatures, as assigned.
• Monitors 24-hour specimen collections (i.e., urine, feces), as assigned.
• Maintains sample collection area clean and stocked with all necessary supplies.
• Notifies appropriate staff of abnormal results while collecting specimens, adverse events, or unusual incidents.
• Acts as courier to the Pharmacokinetic laboratory for collected specimens.
• Assures minimal discomfort for study participants while performing all duties.
• Maintains safety and well-being of study participants during assigned shift.
• Creates safety lab requisitions and manages sample send-out to local labs.
• Labels 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 the company'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.
• Understanding of 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).