Clinical Research Assistant (32611)

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

• Read and understand specific requirements of each study protocol and informed consent form
• Works with study coordinators and other research team members to complete protocol specific procedures and documentation
• Assists in clinic and protocol administration duties including but not limited to:
• Explain the purpose, risks, and benefits of clinical trial participation
• Screen potential candidates in a timely and accurate manner
• Ensure that study patients understand the information presented and agree to the protocol requirements
• Obtain and maintain consent of patients prior to any study-related procedures being performed and with the highest ethical standards
• 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 according to the study specific manuals (lab and procedural)
• Use approved source documents; obtain protocol-specific data to complete and maintain source documents and case report forms (including electronic data capture – EDC) in accordance with applicable regulations and sponsor requirements
• Perform study-specific readings and measurements including but not limited to:
• Vital signs
• ECG
• Photography and videography
• Reports irregular readings and measurements to Investigator and Lead Study Coordinator
• Package and ship laboratory specimens to study-specific destinations
• Complete applicable training requirements and ongoing education as required
• Maintain certifications in, and continually update knowledge of, FDA, GCP, ICH, federal and state regulations, etc.
• Communicate with and support patients and their families as necessary.
• Work with the EMR and data management systems to complete EDC, eCRFs, find patients, maintain records
• Effectively communicate with potential candidates for trials and collect metrics to track progress
• Must have or gain knowledge of relevant software/programs
• Work closely with IRB and study sponsors, PIs and Sub-Is. Attend necessary meetings and calls
• Assist with the development of 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 (site initiation visits, interim monitoring visits, close-out visits, etc.
• Assist study coordinators with necessary study close-out procedures and documentation