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Charlotte, NC, United States
Job ID: 127768
Job Family: Research Services
Status: Full Time
Shift: Day
Detailed Shift and Schedule: 40 hours a week, 5 days a week, daytime shift
Job Type: Regular
Department Name: 11011036640418-Bio Statistics - LCI
Overview
Job Summary
Assist with the compilation of required documents for trial activation. Manage studies to ensure adherence to protocol, Good Clinical Practice (GCP) and regulations, ensuring patient safety, and well-being as well as verifying accuracy of clinical trial data with minimal oversight from mentors/QA manager. Assist in training of research staff. Analyze supplies, procedures, and processes of trials at medical sites and suggest options as needed. Monitor informed consent and eligibility processes.
Essential Functions
Physical Requirements
Education, Experience and Certifications
Excellent written and verbal skills as well as excellent organizational and interpersonal skills. Be familiar with current Good Clinical practices and the Code of Federal Regulations. A Bachelor's degree in a healthcare or other scientific discipline required. At least 4 years’ experience in clinical research at a pharmaceutical company or a Contract Research Organization (CRO) required with at least 2 years auditing / monitoring experience preferred. Alternatively, an equivalent combination of education, training and experience will be considered. Relevant certification (ACRP, SoCRA, Risk Based Quality Management or equivalent) preferred.