Manager, Pharmacokinetic Lab

More About START • West Valley City, UT

5d • Onsite

About The Position

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.

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.
• 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.

Nice To Haves

• 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.

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.

Benefits

• 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 a supportive environment that values balance, wellbeing, and flexibility

What This Job Offers

• Job Type: Full-time
• Career Level: Manager