What are the responsibilities and job description for the Research Associate (31682) position at The Specialty Alliance?
Review and follow Urology AllianceStandard Operating Procedures
Must be willing to gain a thorough knowledge and follow strict adherence of all clinical study protocols.
- 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:
- 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
- ECG
- Urine Pregnancy Test
- Uroflow, PVR, urinalysis, cystoscopy
- Photography and videography
- 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