Pharmacokinetic Lab Manager: Oncology Trials

START Research; Miami (FL); Presencial; USD 90.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k) retirement plan with employer

Annual performance bonus

Paid time off & holidays

Medical, dental, vision coverage

Life and disability insurance

EAP program

FSA/HSA plans

Supportive, flexible environment

Descripción de la vacante

START Research in Miami, FL seeks a Lab Operations Leader to oversee PK Lab processing, SOP development, and regulatory compliance for early-phase oncology trials. The role includes staff hiring, training, and ensuring accurate data management across study forms and shipping records.

Ideal candidates have 5+ years of lab experience, knowledge of GCP/GDPR, and familiarity with EMR/LIS systems. This on-site position offers a comprehensive benefit package and growth opportunities.

Formación

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

Responsabilidades

• Oversee sample processing by PK Lab Technicians and correct inconsistencies in data.
• Create SOPs for the PK Department and Tumor Bank; train staff annually and update SOPs.
• Ensure compliance with Federal, State, and local laws; maintain accurate files.
• Hire, train, and develop employees; supervise personnel.
• Oversee study forms (flowsheets, shipping logs, documents, manifests).
• Track Site Initiation Visits, protocol amendments, and lab manual updates.
• Participate in Protocol Development and Review Committee meetings for phase 1 protocols.

Conocimientos

Quality management

Personnel management

Financial management

Process management

Regulatory knowledge

Educación

Bachelor’s degree in a lab science

Herramientas

EMR systems

LIS systems

Descripción del empleo

The START Center for Cancer Research (“START”) is the world’s largestearly phasesite network, fully dedicated tooncologyclinical research.Throughout ourhistory, START has provided hope to cancer patients inglobalcommunity practices by offering"Hope Through Access”tocutting edgetrials throughout the UnitedStatesand Europe.

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

• 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 coverageand optional insuranceoptions

• Companyp‑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’recommitted to fostering a collaborative, creative workplace where every team member is encouraged to contribute. At START,you’lljoin 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. STARTrepresentsthe 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, STARTtreated the first patient ever with Keytruda –one ofthe most effective cancerdrugsin medical history.

Learn more atSTARTresearch.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. Yourexpertiseand dedication can help us bring hope and healing to patients worldwide.

We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminateon the basis ofrace, 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.