Location: Eatontown,NJ, USA
Description
JOB SUMMARY
The Lab Supervisor is responsible for overseeing the daily activities of the pharmacy and research lab as well as ensuring its proper functioning. The P Lab Manager is responsible for providing clinical evaluation of potential research subjects and providing continuous monitoring throughout the duration of clinical subject participation in trials.
RESPONSIBILITIES
The specific duties of the Lab Supervisor include but are not limited to:
* Supervise the activities of the lab (i.e. ensure tasks related to the function of the lab or pharmacy are performed according to SOP)
* Supervising and Scheduling / Staffing
* Maintain the laboratory facility in a safe, clean, and organized manner.
* Update and develop instructional-related materials applicable to active studies
* Monitor lab equipment performance and usage; maintain equipment as required
* Ensure that the lab staff is checking the diagnostic lab portals daily and reporting any abnormalities with the research subjects to the necessary clinical staff
* Ensuring diagnostic lab forms are properly filled out in accordance with protocol requirements
* Communicate with diagnostic and/or analytical labs to ensure clear and concise instructions, troubleshoot where required
* Responsible for inventory and re-ordering of medical supplies as needed
* Confirm the quality of the work done by the lab staff, including but not limited to proper sample handling, storage, and shipment
* Ensure research samples are being handled in a timely and efficient manner, according to protocol and/or lab manuals provided
* Train new team members
* Act according to Clinilabs Standard Operating Procedures, protocol, GCP, Department of Health (DOH) and Occupational Safety and Health Administration (OSHA) standards
* Comply with federal handling and shipping regulations for biologic specimens
* Create and maintain the accuracy and completeness of all lab source
* Oversee that lab staff has completed the study set up for the following day
* Oversee the organization in the lab area
* Help in training of research assistants on performing lab procedures
* Oversee inventory and supply of all lab control supplies
* Inventory, package, and ship samples to other laboratories
* Maintain and calibrate automated analyzers, laboratory equipment, freezers, refrigerators, and microscopes
* Maintain quality control of lab processes and equipment
* Review all protocols, lab manuals, and other study-related materials and ensure compliance
* Ensure internal/external audits are supported by the operations team
* Assist Clinical Research Coordinators (CRCs) as needed, as well as other clinicians
* Other duties as assigned
Requirements
REQUIRED EDUCATION, KNOWLEDGE, SKILLS AND ABILITIES
* At least two years working in a lab environment, private office, or hospital
* Ability to organize and handle a fast-paced environment
* Experience following research study protocols a plus
* Supervisory experience is a plus
* Interpersonal skills sufficient to effectively interact with patients and Clinilabs staff in fulfilling the duties and responsibilities of the position
* Must be Basic Cardiac Life Support/Automatic External Defibrillator (AED) certified, Good Clinical Practices (GCP), and Hazardous Materials/International Air Transport Association (IATA) certified (training provided)