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Manager, Laboratory Services
3 months ago
The Manager, Laboratory Services works to ensure the execution of assigned lab procedures and overall lab management in compliance with GCP, ICH, FED and HIPAA regulations, company SOPs and policies.
Key ResponsibilitiesEssential Job Duties: Responsibilities may include but are not limited to:
- Overall management of the lab, staff, processes, and quality with a focus on ensuring efficiencies, patient safety, and protocol/GCP/OSHA/regulatory compliance.
- Monitor and maintain both general and study-specific lab inventory, and ensure study-specific lab supplies are ready for new study start-up.
- Oversee specimen shipments to central labs and ensure proper shipping methods have been observed. Manage shipment or transportation of samples.
- Assist with drawing and processing specimens according to each trial’s requirements, as needed
- Oversee 24/7 temperature monitoring systems for ambient/refrigerated/frozen drug and/or lab storage areas at CCRC’s main office and satellite offices. Keep computer documentation with paper backup.
- Schedule calibration of lab equipment and maintain both paper and digital calibration logs/reports
- Responsible for OSHA compliance and reporting as required for laboratory activities, including oversight of proper medical waste disposal and manage medical waste vendors, and ensuring fire code compliance
- Monitor expiration dates on lab equipment and supplies
- Oversee the purchase and pick-up of dry ice. Attempt to minimize company’s dry ice expenses by batch shipping when possible.
- Oversee people management activities including interviewing and selection, performance appraisals, employee counseling, career coaching and termination meetings. Managing assigned site staff, proactively identify and resolve issues, and work to ensure successful site operations.
- Oversee team schedules, timecards, and pay, absence tracking/approvals, new hire orientation and training for assigned staff / teams per operational needs.
- Assist in creating or revising CCRC lab SOP’s
- Complete and renew CITI GCP and IATA training as required.
- Attend SIVs when needed, and complete all sponsor required lab training.
- May support other clinical research related activities such as EDC and QA/Chart review as needed.
- Ensure compliance with company SOPs, FDA/HIPAA regulations, ICF documentation and GCP guidelines.
- Maintain confidentiality of patients, customers and company information, and
- Perform other duties as assigned.
Skills, Knowledge and ExpertiseMinimum Qualifications: An Associate’s degree in a science related field, or certification in the areas of Medical Assisting or Phlebotomy and 5 or more years of related experience, or an equivalent combination of education and experience, is required. Proficiency with phlebotomy, basic lab procedures, and spinning is required. Prior management experience preferred. Bi-lingual (English / Spanish) proficiency is a plus. BLS certified/preferred.
Required Skills:
- Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm).
- Must possess strong organizational, time management, problem solving, and project management skills to meet project deadlines.
- Well-developed written and verbal communication skills.
- Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.
- Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities.
- Must be professional, respectful of others, self-motivated, and have a strong work ethic.
- Must possess a high degree of integrity and dependability.
- Ability to work under minimal supervision, identify problems and implement solutions.
- Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.
Benefits
- Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.
- Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.
