Research Associate (31682)

Responsibilities

• 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:
• Conduct screening procedures and other visit procedures in a timely and accurate manner
• Provide instructions to patients to ensure proper protocol compliance
• Distribute and instill 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
• EKG
• Urine Pregnancy Test
• Uroflow, PVR, urinalysis, cystoscopy
• Photography and videography
• Catheter placement
• Reports irregular readings and measurements to Investigator and Lead Study Coordinator
• Packages and ships laboratory specimens to study-specific destinations
• Completes applicable training requirements and ongoing education as required
• Maintains certifications in, and continually update knowledge of, FDA, GCP, ICH, federal and state regulations, etc.
• Communicates with and supports patients and their families as necessary
• Afford assistance with the development of source documents and phone screen tools
• Manages ancillary supply inventory and assists with drug accountability as needed

Qualifications

• Willingness 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