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About the Role

The Senior RN Clinical Research Coordinator will coordinate and implement complex clinical research studies within the Department of Women's Health at Dell Medical School at The University of Texas at Austin. This role independently manages day-to-day study operations and participant-facing research activities throughout the study lifecycle.

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.

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).
• Relevant education and experience may be substituted as appropriate
• Resume/CV
• 3 work references with their contact information; at least one reference should be a supervisor
• Letter of interest
• Criminal history background check will be required for finalist(s) under consideration for this position.
• If hired, you will be required to complete the federal Employment Eligibility Verification I-9 form.
• 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.
• Failure to do so will result in loss of employment at the university.

Skills

• Clinical research
• Good Clinical Practice (GCP)
• HIPAA
• FDA regulations
• Human subjects research
• Data collection
• Data entry
• Data review
• Data cleaning
• Quality assurance
• Process improvements
• Participant safety
• Regulatory compliance
• Operational efficiency

Location

• AUSTIN, TX

Work Type

• Full-time

Experience Level

• Senior
• At least 5 year(s) of experience in clinical research experience.

Education Level

• Bachelor's Degree in nursing or related field
• Master's Degree in nursing or related field (Preferred)

Salary/Compensations

• $83,500 +

Benefits

• Teacher Retirement System of Texas (TRS) retirement plan eligibility (if position is at least 20 hours per week and at least 135 days in length)

About the Company

• The Department of Women's Health at Dell Medical School at The University of Texas at Austin conducts complex clinical research studies.
• The University of Texas at Austin is an equal opportunity/affirmative action employer.
• The University of Texas at Austin will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
• The University of Texas at Austin uses E-Verify to check the work authorization of all new hires.

Equal Opportunity

• The University of Texas at Austin, as an equal opportunity/affirmative action employer, complies with all applicable federal and state laws regarding nondiscrimination and affirmative action. 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.