POSITION DEFINITION:The PK Department Manager will act as a liaison between START US Sites and the pharmaceutical sponsors by providing information regarding collection, processing, handling, 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.

Tasks and Responsibilities:

• Maintain education and competency requirements for current job title and position.
• 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.
• Responsible for facilitating departmental communication by demonstrating a professional, positive, and helpful attitude in interactions with co-workers both internal and external to the PK Department.
• Work with START Directors and Managers to ensure quality clinical trials operations.
• Work closely with the Regulatory Department to transfer files to off-site storage.
• Participate in Protocol Development and Review Committee meetings by reviewing and providing comments for all phase 1 investigational protocols received by START.
• Attend weekly Phase 1 meetings.
• Track SIVs, amendments and lab manual updates.
• Participate in Form Development Committee meetings.
• Completion of study forms to include but not limited to: PK flowsheets, shipping logs, samples requisition forms, case report forms.
• Maintain distribution lists for PK correspondence of sponsors and monitors for each trial.
• Assist with answering sponsor queries.
• Conduct training of technicians on new study protocols, and changes to ongoing study protocols and maintain training records for all employees.
• Coordinate technician work schedules to include day, night, and weekend coverage.
• Oversee the processing of the samples by PK technicians and take appropriate corrective action to correct inconsistencies in collection tubes and times. Contact the nurse immediately to have the situation corrected before the patient leaves the building.
• Create standard operating procedures (SOPs) for the PK Department and perform an annual review and / or update. Train PK Department staff on all PK Department SOPs, at least annually, when new SOPs are written, and when any updates occur.
• Manage PK temp logs and file in a central location. Participate in On Call Schedule for temperature monitoring.
• Oversee daily and yearly maintenance of equipment.
• Other duties as assigned.

Background REQUIREMENTS:

• Education: Bachelor’s degree in healthcare or science field
• Experience: Five years research laboratory setting experience. Prior experience in Phase I clinical trials a plus. Quality management skills including personnel management, financial management and process management.
• CITI GCP training required within 1 month of hire.
• Knowledge of GCP, GDPR and federal clinical research regulations required in US.
• Familiarity with Microsoft Office applications and clinical documentation systems.