Administrative Skills, Candidate Screening, Clinical Practices/Protocols, Clinical Trial, Communication Skills, Documentation, Establish Priorities, FDA (Food and Drug Administration), Federal Laws and Regulations, GCP (Good Clinical Practices), HIPAA (Health Insurance Portability and Accountability Act), ICH Regulations, IRB/IEC (Institutional Review Board/Independent Ethics Committee), Informed Consent, Inventory Management, Laboratory Techniques, Maintain Compliance, Medications, Operations Processes, Organizational Skills, Patient Education, Regulations, Research Protocols, Specimens/Samples, State Laws and Regulations, Time Management, Urology
LOCATION
Austin, TX
POSTED
22 days ago
Review and follow Urology AllianceStandard Operating Procedures
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:
o Conduct screening procedures and other visit procedures in a timely and accurate manner
o Provide instructions to patients to ensure proper protocol compliance
o Distribute and instill study medications in compliance with protocol randomization requirements
o Learn and understand lab procedures and obtain and process study related lab specimens according to the study specific manuals (lab and procedural)
o 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:
o Vital signs
o ECG
o Urine Pregnancy Test
o Uroflow, PVR, urinalysis, cystoscopy
o Photography and videography
o Catheter placement
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.
Must have or gain knowledge of relevant software/programs
Assist with the development of source documents and phone screen tools
Manage ancillary supply inventory and assist with drug accountability as needed
Maintain HIPAA compliant communication and confidentiality, at all times
Performs other duties as assigned
Must be willing to gain a thorough knowledge and follow strict adherence of all clinical study protocols.
Develop an understanding of and demonstrate Good Clinical Practices (GCPs), learn and comply with all FDA clinical trial and IRB rules and regulations
Effective time management and the ability to prioritize work
Excellent communication skills and the ability to interact with all levels of management, staff, and physicians in person, virtually, and in writing
Ability to be flexible with the day-to-day job requirements to facilitate a successful workflow in clinic
About the Company
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GI Alliance
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