Research Associate (31258)

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