IRB Regulatory and Quality Assurance Specialist

At Urology America, our mission is to support our physician partners in building a premier urology organization that delivers best-in-class patient care and experience, is nationally recognized for its clinical capabilities, and excels in operational performance and growth.

By choosing a career with Urology America and its affiliated practices, you are joining a collaborative, team-driven organization committed to innovation, quality, and compassionate care. Together, we are improving the lives of patients and their families through better medicine and better care, wherever we serve.

Job Summary:
An IRB Regulatory and Quality Assurance Specialist is needed to continue building a growing research department across multiple clinical trial sites that Urology America operates.  The role involves ensuring the ethical and regulatory compliance of clinical research activities, while also maintaining high standards of quality assurance throughout the research process.  You would work closely with Urology America PIs, Sub-Is, and CRCs on various studies for continuous improvement of regulatory and auditing processes.  You will be working with highly motivated large private practice urology groups with 10-40+  providers.  This position is primarily in-person and may require up to 20% travel. 

• Reports to the Clinical Research Manager
• Able to collaborate with all of the Urology America Research teams, CROs, sponsors, IT, patient navigators, and 3^rd party vendors.

• Must have knowledge of and experience with relevant federal and state regulatory guidelines. 
• Must have > 5yrs experience with conducting clinical trials. 
• Urology based clinical experience preferred.
• Experience with evaluating and implementing study protocols.
• Certification via ACRP or the equivalent preferred.
• Proficiency in computer software use, including Microsoft Office, EMR and Practice Management systems.
• Effective time management and the ability to prioritize work.
• Excellent written and verbal communication skills and the ability to interact with all levels of management, staff, and physicians

• Collaborate with Urology America research teams to ensure proper submissions, review, approval, and maintenance of research protocols by the Institutional Review Board (IRB).
• Prepare, track, and maintain all correspondence and regulatory documentation required by the IRB, FDA, sponsors, and other institutional and federal oversight committees, including drafting, and reviewing content as appropriate
• Prepare and submit all regulatory documents to the IRB and other governing bodies to maintain study compliance with GCP, institutional and federal regulations. 
• Maintain study regulatory filing systems (paper and electronic)
• Monitor ongoing studies to ensure compliance with IRB-approved protocols and applicable regulations.
• Conduct comprehensive reviews of research documentation, including informed consent forms, recruitment materials, and study procedures, to ensure accuracy and compliance.
• Provide guidance to researchers on regulatory requirements, ethical considerations, and best practices in clinical research.
• Lead study start-up:  prepare and submit all required regulatory documents for new study applications to ensure successful trial launch
• Independently follow-up and resolve all issues related to regulatory concerns identified during monitor visits. 
• Prepare and submit modifications / amendments, and continuing renewals for ongoing study maintenance in a timely manner
• Conduct study close-out and be accountable for the archiving process which includes ensuring all study related files are prepared for off-site storage in accordance with FDA, other applicable regulatory guidelines, and program SOPs.
• Process safety reports, maintain documentation of PI review and submit safety reports to the IRB as appropriate
• Report non-compliance and unanticipated problems
• Serve as primary resource for Urology America research teams, CROs, and sponsors and provide guidance on regulatory statuses, approvals, and instructions regarding patient consent.
• Stay abreast of new impacts/areas of knowledge and regulatory changes and disseminate this knowledge to the study/operations team.
• Develop, maintain, and update Standard Operating Procedures (SOPs).
• Identify, develop, and implement any necessary revisions to related policies and procedures.
• Develop and implement quality assurance processes to assess the integrity and accuracy of data collection, management, and reporting.
• Perform routine audits and inspections of research activities to identify areas for improvement and to ensure adherence to regulatory standards.
• Collaborate with cross-functional teams to identify potential risks and implement corrective and preventive actions as necessary.
• Maintain up-to-date knowledge of federal, state, and international regulations pertaining to human subjects research and clinical trials.
• Contribute to the development of training programs and materials related to regulatory compliance and quality assurance.
• Conduct Urology America research center audits as the subject matter expert on regulatory and quality matters.
• Update and maintain curriculum vitaes for investigators
• Monitor GCP and IATA training and track certification expirations for MSO research teams to ensure up-to-date knowledge of FDA, GCP, ICH, federal and state regulation
• Assist with other duties assigned, such as but not limited to the following:
• Study coordinator responsibilities to support the needs of Urology Austin’s research team
• Obtain and maintain consent of patients with the highest ethical standards
• Work directly with patients to screen, consent, take history, complete necessary exams including EKG, blood draw, vitals, 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
• Must have or gain knowledge of relevant software/programs
• Have a basic and working knowledge of trial design, statistical methods, etc.
• Triage, record, and report adverse events.  Record and report any protocol deviations
• Always maintain HIPAA compliant communication and confidentiality
• Participate in site visits, SIVs, monitoring, etc.
• Travel to Urology America research sites to conduct audits

• Experience in a large and dynamic organization, especially with business and financial aspects, roles, organizational charts, delegation, and workflows. 
• Knowledge of health care field; medical practice clinical and administrative systems, clinical research field, and sponsor requirements for successful clinical trial completion.
• Understanding of medical and research terminology. 

• Excellence in computer and software systems both in the use and in the evaluation, selection, and integration of these systems.
• Interpersonal and communication both with internal staff and external customers.
• Skill in evaluating and implementing study protocols and budgets.
• Basic skill in reading and interpretation of medical terminology.
• Excellent organizational and time management skills.
• Outstanding verbal and written communication skills.

• Ability to communicate effectively with patients, staff, and external contacts via phone, in person, and through electronic mail.
• Elicit appropriate information for patients to clinic staff.
• 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: Involves sitting approximately 70-90 percent of the day, walking or standing for the remainder. Work may require stooping and bending, mobility to complete patient study visits, and lifting up to 40 pounds.  
• Work environment: Primarily office setting, with time in the clinical setting for patient study visits. Noise level in the work environment is usually moderate. Clean, well-lighted office/clinical environment.
• Will require travel to all Urology America research and clinical locations to meet department demands.