Manager Clinical Research Lab

Manages the day-to-day activities in the Clinical Discovery Institute (CDI) laboratory including the testing performed. Has responsibility for performance of basic through advanced testing procedures on participant products and samples, interpretation of results in accordance with Institutional Review Board (IRB) protocol, regulatory guidelines and organizational policies and procedures. Serves as the designated laboratory general supervisor under CLIA regulations.

The list of essential functions, as outlined herein, is intended to be representative of the duties and responsibilities performed within this classification. It is not necessarily descriptive of any one position in the class. The omission of an essential function does not preclude management from assigning duties not listed herein if such functions are a logical assignment to the position.

• Manages the operations and budget of the CDI laboratory ensuring efficiency of workflow and continuity of services
• Develops and oversees the technical practices of research product design and validation testing for the determination of cellular concentrations; develops or assists in the creation of applicable reports
• Manages Lab SOPs, process validations, CAPA, change controls, planned deviations, environmental assessment; assists with audits and inspections
• Provides technology support for immunohematology research and development to include provision of specialized testing procedures, methods and other needs
• Ensures that standards for compliance, use of equipment, and quality control are met as required by organizational policies and all accrediting, state and/or federal agencies; provides customer and regulatory representation regarding laboratory quality assurance and regulatory affairs, as needed
• Maintains and monitors required records and files, written or electronic
• Participates in the ongoing monitoring for each testing process to identify errors or potential problems leading to errors and takes effective and preventive corrective actions when indicated; participates in process improvement initiatives
• Performs and interprets various testing procedures on participant specimens as well as blood products, repeating tests where appropriate; identifies and resolves critical results related to testing and reports accordingly.

To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

EDUCATION AND/OR EXPERIENCE:

Bachelor's degree in medical technology, healthcare, chemistry, biology, biotechnology or related field from an accredited college or university.  Five (5) or more years of experience in a related field or an equivalent combination of education, certification, training, and/or experience.

CERTIFICATES, LICENSES, REGISTRATIONS AND DESIGNATIONS:

Valid and current Florida Clinical Laboratory Supervisor license in Hematology. Other Florida licenses may be required based on newly implemented testing.

KNOWLEDGE, SKILLS AND ABILITIES:

• Proficient use of high complexity laboratory equipment specifically Flow Cytometry devices
• Knowledge of and ability to interpret and apply federal and state regulations as they relate to quality assurance and regulatory affairs
• Ability to organize work for timely completion
• Ability to work with minimal supervision
• Ability to establish and maintain effective and cooperative working relationships with those contacted in the course of work
• Ability to follow complex oral and written instructions
• Ability to communicate effectively orally and in writing
• Ability to read, write and speak English effectively
• Proficient computer skills including Microsoft Office applications, specifically Excel, and various laboratory reporting programs
• Ability to report to work during a disaster, public health emergency or other catastrophic
• Knowledge of and ability to interpret and apply federal and state regulations as they relate to CLIA lab Management, Good Clinical and Manufacturing Processes. (GCP & GMP)

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

Tasks involves periodic performance of moderately physically demanding work, usually involving lifting, carrying, pushing and/or of moderately heavy objects and materials (up to 50 pounds). Tasks that require moving objects of significant weight require the assistance of another person and/or use of proper techniques and moving equipment.

 

Tasks may involve some climbing, stooping, kneeling, crouching, crawling, walking, standing, and manual dexterity in the operation of equipment. Additional, tasks may involve manual dexterity, visual acuity, hearing acuity, and extended periods of time at a keyboard or work station.

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 inside and/or outside with potential for exposure to adverse conditions, such as inclement weather, atmospheric elements and pathogenic substances. Performance of this job could expose the employee to blood-borne pathogens. The noise level in the work environment is usually moderate.