Manager, Pharmacokinetic Lab

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. This role will act as a liaison between START US Sites and the pharmaceutical sponsors by providing information regarding collection, processing, handling, storage, and shipment of research and clinical laboratory samples to ensure successful execution of the protocol within the SOPs of the department. Provides oversight for lab operations, facilities, SOPs, and quality metrics.
Work Schedule: Monday-Friday 8:00am-5:00pm
Location: 13400 SW 120th St, Miami, FL 33186
Essential 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. Maintain accurate 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.
Required Education and Experience:
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 Education and Experience:
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 p‑aid 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 a supportive environment that values balance, wellbeing, and flexibility
We’re committed to fostering a collaborative, creative workplace where every team member is encouraged to contribute. At START, you’ll join a team that values continuous learning, professional growth, shared ideas, and a culture built on inclusivity and innovation.
More About START
START clinical trial sites have conducted more than 1,000 early-phase clinical trials, including dozens of therapies that were approved by the FDA or EMA. START represents the world’s largest roster of early-phase principal investigators across its Network of clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world via our mission of “Hope Through Access”. As an example, in San Antonio, where START was founded, START treated the first patient ever with Keytruda – one of the most effective cancer drugs in medical history.
Learn more at STARTresearch.com.
Ready to be part of a team changing the future of cancer treatment?
Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online.
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.

Employment type
Active

Work arrangement
No