What are the responsibilities and job description for the Clinical Research Assistant (32611) position at GI Alliance?

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
Urine Pregnancy Test
Uroflow, TRUS, urinalysis, cystoscopy
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
Performs other duties as assigned

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Clinical Research Assistant (32611)