Clinical Research Laboratory Manager
1 week ago
Overview:
Oversees the daily operations within the Clinical Discovery Institute (CDI) laboratory, ensuring the accuracy and reliability of testing conducted.
Responsible for executing a range of testing procedures on participant samples and products, interpreting results in compliance with Institutional Review Board (IRB) protocols, regulatory standards, and organizational policies.
Acts as the appointed laboratory general supervisor in accordance with CLIA regulations.Responsibilities:
The essential functions listed below are representative of the duties performed within this role. They are not necessarily descriptive of any single position in the classification.
The absence of a specific function does not prevent management from assigning additional duties that are logically associated with the position.
Manages the operational aspects and budget of the CDI laboratory to ensure efficient workflows and service continuity.Develops and supervises the technical methodologies for research product design and validation testing aimed at determining cellular concentrations; creates or assists in generating relevant reports.
Oversees laboratory Standard Operating Procedures (SOPs), process validations, Corrective and Preventive Actions (CAPA), change controls, planned deviations, and environmental assessments; supports audits and inspections.
Provides technological assistance for immunohematology research and development, including specialized testing procedures and methodologies.
Ensures compliance with standards for equipment usage and quality control as mandated by organizational policies and all relevant accrediting, state, and federal agencies; acts as a representative for laboratory quality assurance and regulatory affairs as necessary.
Maintains and monitors all required records and files, whether written or electronic.
Engages in ongoing monitoring of each testing process to identify errors or potential issues, implementing effective and preventive corrective actions as needed; participates in process improvement initiatives.
Conducts and interprets various testing procedures on participant specimens and blood products, repeating tests when necessary; identifies and resolves critical results related to testing and reports them accordingly.
Qualifications:
To excel in this role, an individual must successfully perform each essential duty and responsibility. The qualifications listed below represent the knowledge, skills, and abilities required.
EDUCATION AND/OR EXPERIENCE:
Bachelor's degree in medical technology, healthcare, chemistry, biology, biotechnology, or a related field from an accredited institution.
A minimum of five (5) years of experience in a relevant field or an equivalent combination of education, certification, training, and/or experience.
CERTIFICATES, LICENSES, REGISTRATIONS AND DESIGNATIONS:
Current and valid Florida Clinical Laboratory Supervisor license in Hematology. Additional Florida licenses may be required based on newly implemented testing.
KNOWLEDGE, SKILLS AND ABILITIES:
Proficient in the use of high-complexity laboratory equipment, particularly Flow Cytometry devices.
Knowledgeable in interpreting and applying federal and state regulations related to quality assurance and regulatory affairs.
Ability to organize work effectively for timely completion.
Capable of working with minimal supervision.
Adept at establishing and maintaining effective working relationships with colleagues and stakeholders.
Ability to follow complex oral and written instructions.
Effective communication skills, both orally and in writing.
Proficient in reading, writing, and speaking English.
Strong computer skills, including proficiency in Microsoft Office applications, particularly Excel, and various laboratory reporting software.
Willingness to report to work during emergencies or public health crises.
PHYSICAL REQUIREMENTS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Tasks involve periodic performance of moderately physically demanding work, typically requiring lifting, carrying, pushing, and/or moving moderately heavy objects and materials (up to 50 pounds).
Tasks requiring the movement of significant weight may necessitate assistance from another person and/or the use of proper techniques and equipment.
Tasks may involve some climbing, stooping, kneeling, crouching, crawling, walking, standing, and manual dexterity in operating equipment.Additionally, tasks may require manual dexterity, visual acuity, hearing acuity, and extended periods at a keyboard or workstation.
ENVIRONMENTAL REQUIREMENTS:
The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job.
Functions are regularly performed indoors and/or outdoors with potential exposure to adverse conditions, such as inclement weather, atmospheric elements, and pathogenic substances.
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