Research Associate (31258)
The Specialty Alliance · Austin, TX · 3 days ago
ResearchPart-time
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)
- 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
- 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 support patients and their families as necessary
- Affixes to the development of source documents and phone screen tools
- Manage ancillary supply inventory and assist with drug accountability as needed
Qualifications
- 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