Manager, Pharmacokinetic Lab

About the role

The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided hope to cancer patients in global community practices by offering "Hope Through Access" to cutting edge trials throughout the United States and Europe. We are seeking a Manager, Pharmacokinetic Lab.

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.
• Maintain accuracy of patient, study/protocol, and sponsor files.
• 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.

Requirements

• 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.

Preferred

• Prior experience in Phase I clinical trials.
• Knowledge of GCP, GDPR and federal clinical research regulations required in US.
• Experience in data management, logistics, and operations.

Best-in-Class Benefits and Perks

We value the time, talent, and dedication our employees bring to START. Our commitment to your well-being and growth is reflected in a competitive compensation package—based on experience—along with comprehensive benefits designed to support you both personally and professionally:

• 401(k) retirement savings plan with employer match
• Eligibility for an annual performance bonus, based on role and company results
• Generous paid time off and paid holidays
• Comprehensive medical, dental, and vision coverage and optional insurance options
• Company-paid life and disability insurance for added financial protection
• Employee Assistance Program (EAP) providing confidential, no-cost support for you and your family from day one
• Flexible FSA and HSA plans to support your financial wellness

Commitment to Diversity and Inclusion

We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.