Research Associate, Clinical Research

Review and follow Urology Alliance Standard 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 mannero Provide instructions to patients to ensure proper protocol complianceo Distribute and instill study medications in compliance with protocol randomization requirement so 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 signso ECGo Urine Pregnancy Testo Uroflow, PVR, urinalysis, cystoscopyo Photography and videographyo 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
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