Laboratory Manager

Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step.

As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.

Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program.

Job Summary
The Lab manager is responsible for bringing together their managerial skills and knowledge of safety and lab procedures to ensure that laboratories operate smoothly. The Lab Manager will oversee daily operations of the laboratory, including maintaining equipment/inventory, protocols, research inventories, and related inquiries. Managerial duties include scheduling staff, reordering supplies, and maintaining security standards. Perform patient laboratory testing, and quality assurance as it relates to phlebotomy. Analyze and report blood test results for clinical research studies. This is typically a Monday through Friday position, but during high enrolling trials, it is common to work overtime and on some Saturdays.

Duties/Responsibilities

• Supervises lab personnel.
• Coordinates all regulatory and compliance activities.
• Trains staff in specialized lab techniques.
• Serves as Lab Safety officer.
• Perform overall data management of studies — collect, enter, and maintain records for clinical study subjects.
• Ensure all protocol-required procedures and visits occur according to specified guidelines.
• Manage participant enrollment and ensure compliance with the protocol during participant recruitment, informed consent, participant education, eligibility assessment, participant care, and follow-up per protocol.
• Support accurate and timely data entry in electronic databases.
• Create source documentation, assist in the assessment of toxicities/adverse events and reporting serious adverse events per IRB and sponsor requirements.
• Lab Supply Management
• Lab Shipment Management
• Lab Equipment Maintenance Coordination
• Lab Certification Coordination
• Provides medical laboratory diagnostic and therapeutic information, products, and services by establishing specimen preparation procedures; developing and implementing analytical procedures; evaluating laboratory information; reporting results according to protocols mandated by the hospital and public health department.
• Maintains medical laboratory equipment performance by establishing quality standards; developing operations, quality, and troubleshooting procedures; ensuring staff compliance; certifying instrument performance; arranging equipment replacement, service, and repair.
• Maintains medical laboratory supplies inventory by checking stock to determine inventory level; anticipating needed supplies; placing and expediting orders for supplies; verifying receipt of supplies.
• Maintains medical laboratory productivity by monitoring workload of functional areas.
• Maintains quality results by performing proficiency surveys; reviewing quality control and quality assurance programs; making adjustments in policy and procedures; generating reports; maintaining records.
• Maintains medical laboratory information system by identifying information needs and problems; recommending improvements; establishing priorities; testing; writing user manuals; training employees; maintaining security and confidentiality.
• Implements new programs, tests, methods, instrumentation, and procedures by investigating alternatives; preparing proposals; developing and performing parallel testing; monitoring progress.
• Maintains medical laboratory staff by recruiting, selecting, orienting, and training employees.
• Completes operational requirements by scheduling and assigning employees, following up on work results.
• Maintains medical laboratory staff results by counseling and disciplining employees, planning, monitoring, and appraising job results.
• Complies with state and professional continuing education licensure requirements by providing in-service programs and monitoring outcomes.

Required Skills/Abilities

• A bachelor's degree in a laboratory-related area
• 2 years of experience in lab manager position
• Ability to independently manage workflows and prioritize numerous tasks.
• Ability to make independent effective decisions.
• Excellent judgment and ability to interpret information and protocol requirements.
• Aptitude for technical problem-solving.
• Ability to effectively supervise others.
• Excellent organizational skills to formulate and complete vigorous timetables.
• Maintain flexibility and anticipate timeframes to accommodate frames subjects, monitors, and overtime hours during high-enrolling study periods.
• Experience in processing fresh peripheral blood mononuclear cells (PBMC).
• Possess excellent interpersonal skills and collaboration with the research team.
• Regular and punctual attendance.
• Perform other duties as assigned.

Education and Experience

• Bachelor's degree in life sciences or related field preferred
• 5+ years of Laboratory experience in pharmaceutical, CRO, biotech, or related area
• Minimum of 5 years of Line Management Experience preferred; Or equivalent combination of education, training, and experience.

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times

NOTE
The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.