Job Details

Role Description

This is a full-time on-site role as a Clinical Research Coordinator at the research site in Austell, GA. The role involves coordinating and overseeing clinical research activities, including ensuring adherence to protocols, conducting informed consent processes, and managing clinical trial processes.

Qualifications

• Experienced performing Informed Consent and reviewing clinical Protocols
• at least 3yrs Experience in Clinical Research and Clinical Trials
• Strong under understanding of federal regulations under 21 CFR 312 and 21 CFR 812
• Strong research skills
• Experienced in using EDCs, CTMS, IRTs, and eTMFs
• Experienced in mining EMRs for pre-screening activities
• Experienced in working with 3rd party vendors for advertising campaigns
• Demonstrates the importance of maintaining compliance with the protocol, FDA, and IRB and the potential ramifications of non-compliance
• Experienced managing clinical trials from feasibility to start-up to study close-out
• Regulatory experience
• Experience managing multiple complex trial simultaneously
• FDA audit experience is a plus but not required
• Ability to work independently and in a team
• Excellent organizational and communication skills
• Bachelor's degree in a relevant field (e.g., Life Sciences, Nursing, Public Health)
• Certification in Clinical Research is a plus
• license (phlebotomy, MA, LVN, etc) to perform blood draws is highly preferred