Clinical Research Associate: Study Coordination & Patient Care

GI Alliance; Germantown (TN); On-site; USD 52,000 - 76,000; Full time

Job summary

GI Alliance invites qualified candidates for a Clinical Research Coordinator role in Germantown, TN. You will read study protocols, obtain informed consent, and coordinate procedures and documentation across study teams.

You will screen patients, manage data in EMR/EDC, handle specimen logistics, and ensure adherence to HIPAA and regulatory standards throughout site visits and close-out activities.

Responsibilities

• Read and understand specific requirements of each study protocol and informed consent form
• Work with study coordinators and other research team members to complete protocol specific procedures and documentation
• Explain the purpose, risks, and benefits of clinical trial participation
• Screen potential candidates in a timely and accurate manner
• Obtain and maintain consent of patients prior to any study-related procedures
• Provide instructions to patients to ensure proper protocol compliance
• Distribute study medications in compliance with protocol randomization requirements
• Learn and understand lab procedures and obtain and process study related lab specimens
• Use approved source documents and obtain protocol-specific data for source documents and CRFs (including EDC)
• Perform readings and measurements (vital signs, ECG, photography, videography) and report irregular findings
• Package and ship laboratory specimens
• Complete required training and maintain certifications in FDA, GCP, ICH, and state/federal regulations
• Communicate with patients and families and support them as needed
• Work with EMR and data management systems to complete EDC/eCRFs and find patients
• Attend meetings with IRB, sponsors, PIs and Sub-Is and assist with source documents and phone screen tools
• Manage ancillary supply inventory and assist with drug accountability
• Maintain HIPAA compliant communication and confidentiality at all times
• Participate in site visits (start-up, monitoring, close-out) and assist with close-out procedures and documentation

Job description

GI Alliance invites qualified candidates for a Clinical Research Coordinator role in Germantown, TN. You will read study protocols, obtain informed consent, and coordinate procedures and documentation across study teams.

You will screen patients, manage data in EMR/EDC, handle specimen logistics, and ensure adherence to HIPAA and regulatory standards throughout site visits and close-out activities.