Senior Clinical Research Nurse

The University of Texas at Austin•Austin, TX

13d•Onsite

About The Position

The Senior RN Clinical Research Coordinator coordinates and implements complex clinical research studies conducted within the Department of Women's Health at Dell Medical School at The University of Texas at Austin. The position independently manages day-to-day study operations and participant-facing research activities across the study lifecycle, including start-up, recruitment and enrollment, study visits, regulatory and data activities, safety reporting, sponsor and investigator communication, and study close-out.

Requirements

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

Nice To Haves

Master's Degree in nursing or related field.
At least 7 year(s) of experience in clinical research experience.
Advanced certification in Clinical Research (e.g., ACRP-CP).

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 escalate 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 federal, state, and local requirements governing human subjects research.
Maintain accurate and complete study records and support regulatory submissions, continuing reviews, amendments, and other required documentation.
Identify, document, and respond to research-related adverse events and other safety events in accordance with study protocols, institutional requirements, and applicable reporting requirements.
Coordinate appropriate communication and escalation of safety events to investigators, sponsors, regulatory bodies, and other appropriate stakeholders.
Manage research data activities, including data collection, entry, review, cleaning, and quality assurance.
Establish and maintain data collection standards based on study requirements and outcomes.
Develop tools and templates to support consistency, completeness, and data integrity.
Assist with data analysis and preparation of study results and reports.
Evaluate study workflows and implement process improvements that support participant safety, regulatory compliance, data integrity, operational efficiency, and successful study completion.
Serve as a primary clinical and operational point of contact for principal investigators, research staff, clinical providers, sponsors, central and local IRBs, vendors, monitors, and institutional partners.
Communicate study procedures, timelines, requirements, and operational issues clearly and professionally and collaborate across multidisciplinary teams to support successful study implementation and execution.
Coordinate research meetings and project groups, including meeting logistics and documentation of key decisions and action items.
Collaborate with other University departments, schools, affiliated clinical sites, and partner institutions.
Participate in research meetings, trainings, and events and provide study-specific education and training to research and clinical staff, as appropriate.