The MCRU Research Laboratory Tech Lead’s primary function is to provide the infrastructure and logistical support to conduct adult and pediatric human clinical research trials, in accordance with institutional and health center guidelines. The applicant will adhere to regulatory compliance, and demonstrate knowledge of a diverse protocol portfolio associated with MCRU’s research support services. This will include understanding protocol structure, and interpretation of the study to comply with the study parameters.
• Collaborate with the APD to understand, develop, and implement tools to assess study complexity, workload issues, budgetary needs and staffing patterns.
• Lead by example to demonstrate dedication to superior customer service and satisfaction, showing compassion, flexibility and creativity to accommodate participant and/or customer needs.
• Provides oversight of daily laboratory operations
• Onboards new staff members, provide performance coaching and complete performance evaluations, approves payroll and time off requests.
• In partnership with the APD and Faculty Director, may manage hiring, dismissal, and disciplinary actions related to MCRU laboratory personnel
• Prepares regular evaluation metrics, updates leadership on performance, suggests best practice for improving laboratory service function.
• Represents and markets lab services unique to MICHR to the greater institutional community
• Maintain knowledge of laboratory software capabilities, investigate updates and impact to lab workflow.
• Has extensive knowledge of lab equipment (CVC and DF), manages repairs (or arranges repair) and maintenance of lab equipment. Maintains contractual agreement with vendor in partnership with MICHR finance lead.
• Maintain OSHA and Joint Commission standards at both the CVC and DF location.
• Accurately maintains and regularly submits billing reports for lab services rendered.
• Works with the APD and Institutional QA/QC staff to implement a quality assurance/quality control process with staff to assess study and regulatory compliance, data quality, compliance with research billing activities,sample management, and lab practice.
• Works with study teams to develop lab protocols and reference sheets to facilitate individual research studies.
Staffing Responsibilities (30% Allocation)
• Staffs bench (30% of allocation)
• Demonstrates proficiency of processing, shipping and handling of research specimens.
• Demonstrates quality control of research specimens
• Demonstrates the ability to troubleshoot study team problems with collections, kits and/or specimen issues
• Demonstrates proficiency of data entry/ database maintenance
• Demonstrates proficiency of managing clinical trials specimen and data collection, processing, and distribution
• Demonstrates the ability to adhere to deadlines while ensuring specimen collection is performed quickly and effectively within the standards operating procedures
• Demonstrates proficiency to work aseptically
• Demonstrates proficiency to work and maintain GMP and GLP/GCP
• Demonstrates proficiency to assist in billing
• Demonstrates the ability to be accountable for success as well as errors
• Demonstrates the ability to work effectively and function as a team within the lab and the unit
• Demonstrates proficiency to development and modification of protocol – specific SOP’s
• Demonstrates the ability to complete other duties as assigned prioritizing and executing daily laboratory workflow to ensure the MCRU Core lab is performing to a high standard implemented by the Laboratory Supervisor/ Michigan Institute of Clinical Health and Research
• Prioritizes lab staff duties in response to lab function and workload demands.
• Maintains a close working relationship with MCRU Program Director and the Office Coordinator to strategize execution of protocols.
• Promotes teamwork within the lab and across departmental and institutional groups.
• Synthesizes staff schedule/location and approval of schedule variation requests.
BA or BS in science related field with at least 2-3 years lab experience is required. Must have 3+ years of recent research and related clinical trial experience; a sound and in-depth understanding of clinical research; extensive experience with diverse portfolio of sample management; demonstrated ability to function independently as well as in a team environment; and to interact and communicate effectively with the research team. A minimum of three years’ supervisory, or lead experience is needed in a research or health care environment
Understand compliance issues related to human subject research, knowledge and application of Good Lab Practice (GLP) guidelines. Under FLSA, incumbents in this position meet the criteria for exempt status.
At least 5 years lab experience is preferred.
Flexible hours, and rotating Saturdays.
CVC and Domino's Farm
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act.
Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.
Job openings are posted for a minimum of seven calendar days. This job may be removed from posting boards and filled anytime after the minimum posting period has ended.
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The University of Michigan is an equal opportunity/affirmative action employer.