Clinical Research Assistant The Specialty Alliance - 2.4 Lafayette, LA Job Details Full-time 1 day ago Qualifications Medication dispensing Photography Health screenings Patient and family consultation Vital signs HIPAA compliance Informed consent Electronic health records (EHR) management Urinalysis Research ethical considerations Pre-examination patient preparation Professional ethics HIPAA Video shooting Assisting with diagnostic tests and procedures ECG equipment ICH guidelines Records management Clinical data entry Medication supplies Packaging Video recording equipment Informed consent procedures implementation Medical laboratory work experience Data entry Research compliance clinical trial records management Clinical trial standard operating procedures Implementing research protocols Patient recruitment Patient interaction Full 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 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