The laboratory technician performs diagnostic testing and manages laboratory activities including sample collection, processing, and storage. They ensure adherence to clinical protocols, FDA regulations, and GCP standards while maintaining accurate laboratory logs and inventory.
Requirements summary
Candidates must have at least a high school diploma or GED and the ability to work in a fast-paced clinical environment. Preferred qualifications include IATA certification and phlebotomy certification.
high schoolprofessional certificatePhlebotomyChemistryHematologyUrinalysisInventory managementData documentationChain of custodyClinical researchDiagnostic testingGCP complianceFDA regulationsSample collectionLaboratory proceduresSample storageIATA compliance
Job description
About Us
Each of CenExel’s research sites specialize in Phase I to Phase IV clinical trials.
Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country.
Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology.
Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability.
We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.
Job Summary
Performs select diagnostic testing and basic activities necessary to provide laboratory testing services. Testing scope may cross several laboratory disciplines such as hematology, urinalysis, and/or chemistry. Minimal interpretation and judgment are required to perform analytical processes.
Schedule
Monday - Friday mornings and weekends as needed.
Compensation
$19.00 - 23.00/hr. (Depending on education, experience, and skillset)
Essential Responsibilities and Duties
Have full knowledge of laboratory procedures and processes per protocol, laboratory manual, shipping manual, etc.
Assist the laboratory manager in site preparation for study conduct.
Assist in the creation of laboratory documents (i.e. harvest logs, etc.)
Assist in the preparation of collection tubes, vials, study supplies for visits.
Monitor temperature of laboratory sample storage and address any excursions.
Pack and properly label all study materials for storage or return to sponsor upon study close out.
Obtains samples per protocol, performs select diagnostic tests or limited high complexity testing and documents process in source documents.
Assists in gathering data for validations on select instrumentation.
Assists with monitoring supply inventory.
Stores samples in an upright position in appropriate shipping boxes in the freezer. Stores primary and secondary samples in separate shipping boxes.
Ensures freezer/refrigerator temperature is within range for protocol and ensures appropriate logs are kept.
Supports and ensures 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.
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 able to effectively communicate verbally and in writing.
Minimum High School graduate or have GED equivalency.
IATA certification, preferred.
Phlebotomist certification preferred.
Motivated to work consistently in a fast-paced and rapidly changing environment.
Working Conditions
1. Indoor, Clinic environment. 2. Essential physical requirements include sitting, typing, standing, and walking. 3. Lightly active position, occasional lifting of up to 20 pounds. 4. Reporting to work, as scheduled, is essential. 5. This is an on-site work arrangement.
CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.
