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:  START Mountain Region

Essential Responsibilities

• 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.
• Develop employment protocols including employee job descriptions, goals, performance standards, employee performance evaluations and counsel staff on job performance as needed.
• Design and encourage an efficient and quality environment for the PK Department and Tumor Bank.
• Work with START Directors and Managers to ensure quality clinical trials operations.
• Coordinate technician work schedules to include day, night, and weekend coverage.
• 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.
• Oversee the processing of the samples by PK technicians and take appropriate corrective action to correct inconsistencies in collection data and take appropriate corrective action as needed. Contact the nurse immediately to have the situation corrected before the patient leaves the building.
• 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.
• Assist technicians in maintaining adequate documentation, records, and interactions with study personnel.
• 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.
• Oversee study specific and departmental inventory control and re-supply of reagents and supplies as needed.
• Ensure maintenance of distribution lists for PK correspondence of sponsors and monitors for each trial.
• Oversee maintenance, certifications, and calibrations of equipment as applicable.
• Oversee cleaning and sanitation of laboratory and equipment.
• Oversee management of electronic temperature monitoring system and response to warnings and alarms.
• Participate in on-call rotation for emergency management.
• Performs monthly administrative functions within the PK Department and Tumor Bank, to include:
• Statistical counts of the samples for documentation and billing.
• Review of monthly statements for consistency and correctness before turning over to accounting department.
• Scanning of department and study documents for documentation and billing.
• Contribute to preparation of annual department budget as requested.
  

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.
• Strong interpersonal skills to lead effective teams, resolve conflict, solve problems and communicate in a fast-paced work environment.
• General knowledge of medical terminology.
• High attention to detail and strong organizational skills.
• Ability to work well independently.
• Organizational skills to troubleshoot unplanned situations while still meeting established deadlines.
• Microsoft office suite AND ability to learn new software.
• Use of electronic medical record program(s) and laboratory information systems.
• Must maintain punctuality, good attendance and be flexible to work hours to accommodate clinic patient schedule.
  
  

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.
• Experience in 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.