Pharmacokinetic Lab Manager — Clinical Trials Leader

START Research; Los Angeles (CA); On-site; USD 75,000 - 105,000; Full time

Benefits offered by this job

401(k) retirement savings plan with-em

Annual performance bonus

Paid time off and holidays

Medical, dental, and vision coverage

Life and disability insurance

Employee Assistance Program (EAP)

Flexible FSA/HSA plans

Collaborative work environment

Professional growth opportunities

Job summary

START Research in Los Angeles is seeking a Manager, Pharmacokinetic Lab to coordinate PK sample handling, SOPs, and quality metrics across US sites to ensure protocol execution within SOPs. The role acts as a liaison between START US Sites and pharmaceutical sponsors.

You will oversee PK lab staff, develop SOPs for the PK Department and Tumor Bank, manage training, and ensure compliance with federal/state regulations. Competitive base salary offered.

Qualifications

• Bachelor’s degree in a chemical, physical, biological, or clinical laboratory science or medical technology.
• At least five years laboratory setting experience.
• Quality management skills including personnel management, financial management and process management.
• Experience with electronic medical record program(s) and laboratory information systems.

Responsibilities

• Oversee the processing of the samples by PK Lab Technicians and take appropriate corrective action to correct inconsistencies in collection data, as needed.
• Create standard operating procedures (SOPs) for the PK Department and Tumor Bank and perform an annual review and / or update.
• Oversee or delegate training of PK Department staff on all PK Department SOPs, at least annually, when new SOPs are written, and when any updates occur.
• Ensure compliance with all applicable Federal, State, and local laws and regulations as they apply to biological sample processing, handling, and shipping.
• Perform hiring, training, and development of employees. Supervise all personnel and new hires.
• Oversee and complete study forms to include but not limited to: PK flowsheets, shipping logs, shipping documentation, sample requisition forms, flow sheets, and sample manifests.
• Track Site Initiation Visits, protocol amendments and lab manual updates.
• Participate in Protocol Development and Review Committee meetings by reviewing and providing comments for all phase 1 investigational protocols received by START.

Job description

START Research in Los Angeles is seeking a Manager, Pharmacokinetic Lab to coordinate PK sample handling, SOPs, and quality metrics across US sites to ensure protocol execution within SOPs. The role acts as a liaison between START US Sites and pharmaceutical sponsors.

You will oversee PK lab staff, develop SOPs for the PK Department and Tumor Bank, manage training, and ensure compliance with federal/state regulations. Competitive base salary offered.