teaching, anatomy, compliance, sanitation, hipaa compliance, research, organized, medical devices, evaluations, hipaa, laboratory, medical
Performed clinical research study procedures including but not limited to: Vital signs, ECGs, blood draws, and medication administration, as well as documentation of adverse events, protocol deviations, and drug-drug interactions.
Performed clinical assessment, planning, and documentation of study subjects, including but not limited to: Vital signs, laboratory results, and adverse event reports.
Participates in the development of a new study Coordinator for the clinical trial. Coordinates the training of the study coordinators and the pharmacy staff.
Assists in the preparation of clinical documentation for the study Coordinator and the sponsor and the FDA. Perform all aspects of the clinical research process.
Ensuring that all clinical documentation is completed and accurate, including the study data, source documents, and the study files in accordance with the protocol, the SOPs, and the monitoring plan.
Performed all aspects of the clinical research process including: Computer data entry, source document verification, and drug accountability, and shipping and receiving of biomedical specimens.
RESEARCH LABORATORY TECHNICIAN
Organized and conducted laboratory safety evaluations for the medical lab and the hospital. Performed all duties in accordance with standard operating procedures.
Participated in the development of a research project for the FDA and USDA for the food and drug administration (FDA) and the EPA and OSHA.
Maintained compliance with all state and federal regulations for the sanitation and infection control of the lab. Assisted in the preparation of the MSDS sheets for the department.
Maintain a clean and safe environment for the lab and ensure proper documentation. Participate in continuing education programs. Maintain compliance with all regulatory agencies.
Assisted in the development of a new animal model for the use of the FISH and organ transplant. Performed all the duties of the lab and the documentation of the results of the veterinarian.
Assisted in the preparation of protocols for CAP accreditation and participated in CAP proficiency testing. Ensured compliance with HIPAA and other regulatory agencies.