Senior Clinical Research Nurse — Women’s Health Studies

The University of Texas at Austin; Austin (TX); On-site; USD 75,000 - 92,000; Full time

Job summary

Senior Clinical Research Nurse at The University of Texas at Austin, Dell Medical School, Department of Women’s Health, coordinates and implements complex clinical studies from start-up to close-out. The role manages day-to-day operations, regulatory tasks, and participant-facing activities with a focus on safety and data integrity.

The Senior RN coordinates study start-up, enrollment, visits, and regulatory compliance, ensuring adherence to GCP, HIPAA, and sponsor requirements while

Qualifications

• Bachelor's Degree in nursing or related field.
• At least 5 year(s) of experience in clinical research.
• Registered Nurse (RN) license.
• Certification in Clinical Research (e.g., CCRP).

Responsibilities

• Coordinate and implement multiple complex clinical research studies, including day-to-day study management and operations.
• Develop and maintain project plans and other tools to track study timelines, milestones, deliverables, and requirements.
• Proactively identify and resolve operational issues and elevate complex matters as appropriate.
• Manage study start-up activities, including obtaining study materials and ensuring required regulatory documentation is completed through institutional processes.
• Coordinate study close-out activities and ensure study requirements and documentation are completed appropriately.
• Identify and screen potential participants, obtain informed consent, enroll participants, schedule visits, and conduct participant-facing study visits and procedures.
• Monitor participants and collect required clinical and research data in accordance with study protocols.
• Manage study drug and study device dissemination and accountability, as applicable.
• Complete required data collection, specimen processing, and activities associated with study monitoring visits.
• Provide participants and their families with education regarding study procedures and requirements.
• Maintain regulatory documentation and support compliance with institutional policies, sponsor requirements, Good Clinical Practice (GCP), HIPAA, FDA regulations, and other applicable requirements.
• Maintain accurate and complete study records and support regulatory submissions, continuing reviews, amendments, and other required documentation.

Skills

RN license

Clinical research coordination

Education

Bachelor's Degree in nursing or related field

Master's Degree (preferred)

Job description

Senior Clinical Research Nurse at The University of Texas at Austin, Dell Medical School, Department of Women’s Health, coordinates and implements complex clinical studies from start-up to close-out. The role manages day-to-day operations, regulatory tasks, and participant-facing activities with a focus on safety and data integrity.

The Senior RN coordinates study start-up, enrollment, visits, and regulatory compliance, ensuring adherence to GCP, HIPAA, and sponsor requirements while