Observe and follow all chemical hygiene and lab safety regulations.Perform / prepare solutions, dilutions, and calculations required and as needed.Prepare / organize study specific supplies in preparation protocol activities.Document each stage of processing in compliance with approved protocol and lab manual.Identifies and reports problems with specimens, processing, storage, or anything that will impact the study or integrity and viability of the specimen.Receives, sorts, centrifuge, rack, aliquot, and store laboratory specimens in compliance with the IRB approved protocol and the final version of the protocol-specific laboratory manual.Collect laboratory specimen which may include blood, urine, saliva, emesis, and stool, etc.Demonstrates ability to execute the job duties assigned to the activities related to study protocols.Competency (knowledge, skills, and abilities)
- Good Laboratory Practices - a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical (including pharmaceuticals) non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests.
- Good Clinical Practice (GCP) - quality standards that is provided by ICH, an international body that defines a set of standards, which governments can then transpose into regulations for clinical trials involving human subjects.
- measures.
- Demonstrate the proficiency in assigned tasks and the ability to actively learn and understand the implications of new information for both current and future problem-solving and decision-making needs. Especially as it pertains to new technology and laboratory medicine.
- Demonstrate the ability to adapt and operate by the needs of unique client protocols; perform laboratory testing according to established standards and regulations.
Work Relationships
- Works closely with Project Managers, Clinical Research Coordinators, Research Associates, Medical Laboratory Technologist, and Principle Investigators.
- External relationships include Sponsors, External Vendors, Participants.
Other Duties
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.