Clinical Research Assistant (32212)

GI Alliance; Lafayette (LA); On-site; USD 48,000 - 60,000; Full time

Job summary

GI Alliance in Lafayette, LA, seeks a clinical study coordinator to support protocol-based procedures and documentation. You will explain study purposes, screen candidates, obtain consent, and ensure patient understanding and protocol compliance.

Responsibilities include lab procedures, data capture (EDC/CRF), coordinating with IRB and sponsors, and maintaining source documents per regulations. Experience in EMR/EDC and HIPAA practices is essential.

Qualifications

• Explain the purpose, risks, and benefits of clinical trial participation.
• Screen potential candidates in a timely and accurate manner.
• Obtain and maintain informed consent per protocol requirements.
• Maintain HIPAA compliant communications and confidentiality at all times.

Responsibilities

• 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.
• 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
• 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

Skills

Clinical research coordination

HIPAA compliance

Protocol comprehension

Data entry/EDC familiarity

EMR systems

Tools

EMR systems

EDC software

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