Job Summary: Manages all lab areas and personnel by overseeing daily operational and technical functions with a focus on project completion and resource management. Responsible for ensuring compliance with policies and procedures. Other responsibilities include supervising daily responsibilities of lab personnel, safety of participants, and study conduct.
Compensation: $78,642 - $90,000 annually depending on experience, education, and skillset.
Essential Responsibilities and Duties:- Ensures all lab processes for studies are carried out properly and accurately by the lab team.
- Ensures all tracking systems are adhered to and all protocol required lab procedures are carried out appropriately.
- Makes appropriate staffing assignments, ensuring delegated tasks are within an employee's scope of practice.
- Responsible for the day-to-day operations of the medical testing laboratory.
- Ensures the quality and accuracy of test results.
- Oversees the inventory, maintenance, and validation of laboratory equipment.
- Performs regular inventory of supplies and orders as needed to ensure the lab supplies are adequate and available for study visits.
- Develops and implements procedures to ensure the safety and security of the laboratory.
- Reads and understands protocol requirements for blood specimens including blood collection, labeling of samples, processing samples, storage of samples and shipping of samples.
- Notifies the appropriate lab that the shipment has been sent, including the protocol number, site number and PI's name. Communicates required shipment information including protocol number, site number, PI's name, etc. Acts as a contact point for outside inquiries.
- Ensures storage and tracking system is set up prior to starting the study, with a method of storing the samples in appropriate containers. Primary and back-up samples are stored independent of each other.
- Hires, trains, supervises, and evaluates personnel. Champions and enforces the strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site Working Practices, protocol, and company guidelines and policies. Retrains and implements corrective and preventative actions, as needed.
- Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.
Education/Experience/Skills:- Must be a high school graduate or have GED equivalency.
- Must have experience processing samples.
- Must have experience supervising lab technicians.
- Phlebotomist certification preferred.
- Must have good interpersonal skills, demonstrated through interactions with patients, staff, Sponsor representatives, etc.
- Must be self-motivated, organized and able to perform tasks independently.
- Must be able to effectively communicate verbally and in writing.
Working Conditions - Indoor, Clinic environment.
- Essential physical requirements include sitting, typing, standing, and walking.
- Lightly active position, occasional lifting of up to 20 pounds.
- Reporting to work, as scheduled, is essential.
- This is an on-site work arrangement.
