Clinical Research Assistant

About this role

• * 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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