Clinical Research Assistant (30795)

About the role

Experienced Medical Assistant or Research Assistant needed to contribute to Urology Austin’s growing research department. Research Assistant (RA) roles often transition to Clinical Research Coordinator (CRC) roles and open the door to many other career opportunities within the industry.

Responsibilities

• Review and follow Urology Austin Standard 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
• Aids in clinic and protocol administration duties including but not limited to:
• Explain the purpose, risks, and benefits of clinical trial participation
• Screens potential candidates in a timely and accurate manner
• Ensures that study patients understand the information presented and agree to the protocol requirements
• Obtains and maintains consent of patients prior to any study-related procedures being performed and with the highest ethical standards
• Provides instructions to patients to ensure proper protocol compliance
• Distributes study medications in compliance with protocol randomization requirements
• Learns and understands lab procedures and obtains and processes study related lab specimens according to the study specific manuals (lab and procedural)
• Uses approved source documents; obtains 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
• Performs study-specific readings and measurements including but not limited to: Vital signs, ECG, URG, Urine Pregnancy Test, Uroflow, TRUS, urinalysis, cystoscopy, Photography and videography
• 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 updates knowledge of, FDA, GCP, ICH, federal and state regulations, etc.
• Communicates with and supports patients and their families as necessary
• Works with the EMR and data management systems to complete EDC, eCRFs, find patients, maintain records
• Effectively communicates with potential candidates for trials and collects metrics to track progress
• Must have or gain knowledge of relevant software/programs
• Works closely with IRB and study sponsors, PIs and Sub-Is
• Attends necessary meetings and calls
• Aids in the development of source documents and phone screen tools
• Manages ancillary supply inventory and assists with drug accountability
• Maintains HIPAA compliant communication and confidentiality, at all times
• Assists study coordinators with necessary study close-out procedures and documentation
• Performs other duties as assigned

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
• Urology based clinical experience preferred
• Should possess or develop proficiency in computer software use, including Microsoft Office, EMR and Practice Management systems, and study specific EDC and IVRS systems
• 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

Skills

• Knowledge of health care field; medical practice clinical and administrative systems, departments, and practices, including clinical financial policies and reimbursement payment requirements
• Understanding of medical terminology
• Ability to use multi-line phone systems and basic computer systems
• Interpersonal and communication both with internal staff and external customers
• Ability to evaluate and implement study protocols and budgets
• Ability to read and understand information and ideas presented in writing
• Ability to apply general rules to specific problems to produce answers that make sense – deductive reasoning

Performance Requirements

• Knowledge of health care field; medical practice clinical and administrative systems, departments, and practices, including clinical financial policies and reimbursement payment requirements
• Understanding of medical terminology
• Ability to use multi-line phone systems and basic computer systems
• Interpersonal and communication both with internal staff and external customers
• Ability to evaluate and implement study protocols and budgets
• Ability to read and understand information and ideas presented in writing
• Ability to apply general rules to specific problems to produce answers that make sense – deductive reasoning

Physical Demands And Work Environment

• Primarily office setting
• No direct reports at this time, can change as department grows