Senior Clinical Trials Nurse

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.

Senior Clinical Research Nurse

Department of Women's Health

Immediately

Coordinate Clinical Research Studies

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.

Manage study start-up activities, including obtaining study materials and ensuring required regulatory documentation is completed through institutional processes.

Monitor participants and collect required clinical and research data in accordance with study protocols.

Complete required data collection, specimen processing, and activities associated with study monitoring visits.

Regulatory Compliance and Safety

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.

Data Management and Quality Assurance

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.

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., 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., Working Environment/EQUIPMENT

Standard office equipment.

Required Materials

Retirement Plan Eligibility
The retirement plan for this position is Teacher Retirement System of Texas (TRS), subject to the position being at least 20 hours per week and at least 135 days in length.

The University is committed to a policy of equal opportunity for all persons and does not discriminate on the basis of race, color, national origin, age, marital status, sex, sexual orientation, gender identity, gender expression, disability, religion, or veteran status in employment, educational programs and activities, and admissions.

However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

You will be required to present acceptable and original documents to prove your identity and authorization to work in the United States. Documents need to be presented no later than the third day of employment. E-Verify Poster (English and Spanish) [PDF]

Right to Work Poster (English) [PDF]

Right to Work Poster (Spanish) [PDF]

Employees may be required to report violations of law under Title IX and the Jeanne Clery Disclosure of Campus Security Policy and Crime Statistics Act (Clery Act) and the Clery Act requires all prospective employees be notified of the availability of the Annual Security and Fire Safety report.