Associate or Bachelors degree in a biomedical discipline or related scientific discipline, or equivalent experience and education. Good communication skills with the ability to interact with the Principal Investigator, Sub-Investigators, and Frontage Clinical Services and sponsor personnel. Completion and certification of Medical Assistant course from an accredited or allied health training school. Experience working in a clinical or safety lab.
Experience: 1-3 years experience in clinical research is desirable. Knowledge of FDA regulatory requirements is necessary or on job mandatory training will be required.
Assist Lab Manager in any task as needed.
Develop a high level of familiarity and knowledge of the study protocol and flow chart of study procedures. Develop a strategy for implementing study procedures in compliance with study protocols.
Performs laboratory procedures (g., preparation for admission testing, safety labs, and processing of biological specimen samples, shipment of samples and documentation of sample processing steps, etc.) as required by study protocol under the supervision of the Clinical Research Coordinator, Principal Investigator, and Sub-Investigators.
Prepares sample tubes and labels for the collection of biological specimens, processes and packages biological specimens for shipment.
Reviews sample pick up and refrigerator log.
Monitors freezers and refrigerators through the REES temperature monitoring system and responds to alerts in order to protect the samples.
Updates freezer inventory.
Evaluates and reviews laboratory study data to ensure accuracy and completeness.
Labeling, taping (e.g., sample collection and transfer tubes, safety labs, urine cups, etc.)
Perform study procedures (g., venipunctures, obtain and process biological specimen samples, vital signs, safety assessments, etc.) as required by study protocol under the supervision of the Principal Investigator and Sub-Investigators; Director, Associate Director, CRC Clinical Operations; Manager, Clinical Operations; Senior Clinical Research Coordinators; and Clinical Research Coordinators.