Clinical Research Assistant: Launch Your Research Career

GI Alliance; Austin (TX); On-site; USD 42,000 - 62,000; Full time

Job summary

Urology Austin seeks an experienced Medical Assistant or Research Assistant to support the clinical research team, handling subject recruitment, testing, lab specimen collection, and patient communications. The role collaborates with study coordinators, the Clinical Research Director, and investigators to ensure protocol compliance and accurate data capture.

The position emphasizes adherence to GCP, FDA regulations, and HIPAA, with responsibilities spanning consent, data entry (EDC/IVRS),

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
• Must have > 1 year experience as a medical assistant or research assistant.

Responsibilities

• Review and follow Urology Austin Standard Operating Procedures
• Read and understand specific requirements of each study protocol and informed consent form
• Work with study coordinators and other research team members to complete protocol specific procedures and documentation
• Assist in clinic and protocol administration duties including but not limited to: Explain the purpose, risks, and benefits of clinical trial participation
• Screen potential candidates in a timely and accurate manner
• Ensure that study patients understand the information presented and agree to the protocol requirements
• Obtain and maintain consent of patients prior to any study-related procedures
• Provide instructions to patients to ensure proper protocol compliance
• Distribute study medications in compliance with protocol randomization requirements
• Learn and understand lab procedures and obtain and process study related lab specimens
• Use approved source documents; obtain protocol-specific data to complete and maintain source documents and case report forms (including electronic data capture – EDC)
• Perform study-specific readings and measurements including vital signs, ECG, urine pregnancy test, uroflow, TRUS, urinalysis, cystoscopy
• Photograph and videography where needed
• Report 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 FDA, GCP, ICH, federal and state regulations, etc.
• Communicate with and support patients and their families as necessary
• Work with the EMR and data management systems to complete EDC, eCRFs, find patients, maintain records
• Effectively communicate with potential candidates for trials and collect metrics to track progress
• Must have or gain knowledge of relevant software/programs
• Work closely with IRB and study sponsors, PIs and Sub-Is. Attend necessary meetings and calls
• Assist with the development of source documents and phone screen tools
• Manage ancillary supply inventory and assist with drug accountability
• Maintain HIPAA compliant communication and confidentiality at all times
• Participate in site visits (site initiation visits, interim monitoring visits, close-out visits)
• Assist study coordinators with necessary study close-out procedures and documentation
• Performs other duties as assigned

Skills

GCP knowledge

EMR proficiency

Lab procedures

Communication skills

Time management

Tools

EMR

EDC

IVRS

Practice management

MS Office

Job description

Urology Austin seeks an experienced Medical Assistant or Research Assistant to support the clinical research team, handling subject recruitment, testing, lab specimen collection, and patient communications. The role collaborates with study coordinators, the Clinical Research Director, and investigators to ensure protocol compliance and accurate data capture.

The position emphasizes adherence to GCP, FDA regulations, and HIPAA, with responsibilities spanning consent, data entry (EDC/IVRS),