Clinical Research Coordinator Full-time

Clinical Research Coordinator

The Department of Neurosurgery serves as a site in the Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Network, a multicenter clinical trial network focused on accelerating the development of new therapies for traumatic brain injury. The network includes leading trauma centers and research institutions across the United States and conducts studies utilizing imaging, blood-based biomarkers, and interventional clinical trials to improve the diagnosis and treatment of traumatic brain injury.

The TRACK-TBI Lab at UT conducts observational and interventional clinical research in collaboration with Dell Seton Medical Center, Austin's Level I trauma center. Research staff work with physicians, coordinators, sponsors, and investigators to enroll and follow trauma patients.

This is a fixed-term position with an anticipated end date of August 31, 2028, with the opportunity for renewal based on funding availability and satisfactory work performance.

Purpose

The Clinical Research Coordinator plays a critical role in executing observational and interventional research studies under the direction of the Clinical Research Manager. This position is responsible for participant screening and enrollment, study visit coordination, data and regulatory management, and collaboration with multidisciplinary teams.

The role works in fast-paced clinical environments with diverse patient populations and independently manages research activities while ensuring participant safety, protocol compliance, and data quality.

Responsibilities

Participant Screening and Enrollment

• Execute clinical research protocols by enrolling trauma patients into time-sensitive clinical trials.
• Screen patients through medical record review, collaboration with study physicians and clinical staff, and communication with patients and families to determine study eligibility.
• Approach trauma patients and families to explain research studies and obtain and document informed consent in accordance with protocol, IRB, site SOPs, and regulatory requirements.
• Coordinate baseline assessments, blood collections, participant randomization, and investigational product administration.
• Process blood specimens according to protocol requirements, including operation of investigational devices and laboratory equipment as applicable.
• Collaborate with investigators, hospital clinical staff, and sponsors to facilitate participant enrollment and protocol compliance.

Participant Follow-Up Visit Coordination

• Coordinate and conduct protocol-required follow-up visits.
• Communicate with study participants regarding study requirements, scheduling, and follow-up activities.
• Collect MRI, neuropsychological, clinical, and outcomes data according to study protocols.
• Perform investigational product accountability and maintain study-associated documentation.
• Perform phlebotomy, collect vital signs, and process biological specimens.
• Monitor participant safety and communicate adverse events and participant concerns to study physicians as appropriate.

Data Management and Quality Assurance

• Collect, document, and enter participant data into Case Report Forms (CRFs), Electronic Data Capture (EDC) systems, and other study databases.
• Extract clinical data from electronic medical records for entry into EDC systems.
• Resolve data queries and perform quality control reviews to ensure data accuracy, completeness, and protocol compliance.
• Maintain study records and source documentation in accordance with sponsor, institutional, and regulatory requirements.
• Ensure timely and accurate data entry, verification, and reporting.

Regulatory Compliance

• Ensure compliance with study protocols, institutional policies, Good Clinical Practice (GCP) guidelines, and applicable federal, state, sponsor, and institutional requirements.
• Maintain study regulatory binders, essential documents, and study files according to institutional and regulatory requirements.
• Collect and report adverse events, protocol deviations, and other reportable information according to established timelines.
• Participate in monitoring visits and respond to sponsor and monitor requests, findings, and follow-up actions.
• Ensure readiness for audits, inspections, and monitoring activities.

Training and Administrative Support

• Support the onboarding, training, and mentorship of research assistants and junior research staff.
• Develop and maintain study-specific training materials, workflows, and documentation.
• Assist with financial management activities, including tracking study expenditures, purchasing, and participant incentive reconciliation.
• Participate in study start-up, close-out, and operational planning activities.
• Perform other duties as assigned.

Marginal or Periodic Functions

• Adhere to internal controls and reporting structure.
• Perform related duties as required.

Knowledge, Skills, and Abilities

Interpersonal Savvy and Participant Engagement

• Build rapport and trust quickly with participants and family members from diverse backgrounds.
• Communicate complex study information in clear, approachable language.
• Demonstrate skill engaging and recruiting patients in acute-care settings, including individuals experiencing physical trauma, cognitive impairment, and other complex clinical circumstances.
• Navigate sensitive, emotionally charged, and time-sensitive interactions while maintaining professionalism, empathy, and sound ethical judgment.
• Promote participant retention through strong relationship-building.

Clinical Research Operations

• Demonstrate working knowledge of Good Clinical Practice (GCP), human-subject protections, and regulatory documentation requirements, including informed consent, adverse-event reporting, and investigational product accountability.
• Comply with study protocols, standard operating procedures, and institutional policies.
• Apply medical terminology and clinical knowledge in conducting research activities.
• Maintain accurate, complete, and timely study documentation and data entry with meticulous attention to detail.
• Learn and work effectively across EDC, EHR/EMR, and other research systems.

Goal Orientation, Judgment, and Adaptability

• Meet enrollment and retention goals while maintaining participant safety, ethical conduct, and protocol compliance.
• Demonstrate persistence, initiative, and resourcefulness in identifying and addressing barriers to participant recruitment and follow-up.
• Work independently with minimal supervision, taking ownership of outcomes and study objectives.
• Exercise sound judgment and critical thinking to resolve participant, regulatory, and operational issues.
• Adapt quickly to protocol amendments, sponsor directives, and changing study needs.

Required Qualifications

• Bachelor's degree in a health, life science, psychology, public health, neuroscience, or related field.
• Minimum of two years of experience working directly with patients, research participants, or other diverse populations in healthcare, research, behavioral health, social services, community outreach, or related settings.
• Ability to work comfortably in a clinical environment, including the emergency department.
• Ability to work a flexible schedule, including evenings and weekends, to support enrollment goals and accommodate participant follow-up visit availability.
• Ability to obtain and maintain external partners' site-specific clinical privileges, including required immunizations.

Relevant education and experience may be substituted as appropriate.

Preferred Qualifications

• Master's degree in Nursing, Public Health, Allied Health, Psychology, Neuroscience, or a related field.
• Minimum of three years of experience coordinating human subjects research or clinical research trials.
• Clinical or research experience in emergency department, intensive care, trauma, neurology, neurosurgery, or psychiatry settings.
• Fluency in Spanish with the ability to communicate in a clinical environment.
• Phlebotomy competency.

Salary Range

$53,464+ depending on qualifications

Working Conditions

• Standard office equipment.
• Repetitive use of a keyboard.
• Work in a clinical environment, including the emergency department.
• Flexible schedule, including evenings and weekends, as needed to support participant enrollment and follow-up activities.

Required Materials

• Resume/CV
• 3 work references with their contact information; at least one reference should be from a supervisor
• Letter of interest