Lead Clinical Research Coordinator, Computational Psychiatry

With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report, we invest in you with opportunities for career growth and development to align with your future goals.

About the role

The Computational Psychiatry Program is hiring a Clinical Research Coordinator (CRC) Lead to play a central role in identifying, recruiting, and consenting participants for a longitudinal study involving continuous wearable sensor data collection and clinical outcome tracking. This position offers a meaningful opportunity to contribute to cutting-edge psychiatric research while working directly with individuals with bipolar disorder and major depression.

Responsibilities

• Maintains required subject documentation for each study protocol.
• Directly interacts with clinical research participants, as required, for the research study (non-clinical and clinical procedures). Interacts via telephone, telehealth or in-person.
• Coordinates regulatory documentation for research studies that includes maintaining information to comply with industry standards, University policies, FDA requirements or other hospital policies.
• Coordinates and schedules procedures as per research study. A non-licensed coordinator may pend study order sets with oversight by PI.
• Screens, recruits, enrolls and follows subjects according to research protocol guidelines (non-clinical and clinical procedures). May also assist with the consent processes.
• Maintains and coordinates data collection information required for each study that may also include developing CRFs (case report form) or data collection tools.
• Assists in developing and implementing research studies, may include writing clinical research protocols.
• Conducts research procedures according to the protocol with proper training and check offs to maintain scope of service.
• May provide supervision to other members of the research team as necessary.
• May perform research billing activities, as needed, based on size of department (including linking patient calendars).
• Monitors patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards.
• Assists PI/supervisor with daily activities of the research team and functions as a liaison between clinical research investigators and various organizations/departments and agencies including, but not limited to HRPP, FDA, Sponsored Programs, and affiliated hospitals.
• Coordinates data management and collection for national (larger/more complex) research studies.
• Serves as lead in preparing annual reports for federal, state, and/or local agencies on assigned studies.
• Prepares protocols for Institutional Review Board (IRB) submission. May also submit amendments and continuing review documents.
• Assists and monitors and/or maintains research study budgets. Assists the PI with the fiscal management of the trial. Ensures that the patient care charges are allocated appropriately for various research studies.
• Provides in-service training to all study team members and communicates to involved groups.
• Reviews research study protocols to ensure feasibility requirements of the study.
• Assists in developing website or other social media for marketing/recruiting based on assigned clinical research study.
• Enters data in the assigned clinical trial management system, electronic medical record and/or other required data entry systems.
• Duties performed may include one or more of the following core functions:
  • Directly interacting with or caring for patients;
  • Directly interacting with or caring for human-subjects research participants;
  • Regularly maintaining, modifying, releasing or similarly affecting patient records (including patient financial records); or
  • Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records.
• Performs other duties as assigned.

Requirements

• Bachelor's Degree in medical or science related field.
• 4 years of clinical research experience with Bachelor's Degree.
• Prior experience in the UTSW clinical research mentoring program is highly desirable, and participation in the UTSW clinical research mentoring program may count as additional experience.
• May consider additional years of experience or advanced degree in lieu of education or experience, respectively.

Preferred Qualifications

• Strong proficiency in REDCap, EPIC, ETHOS, Velos, Florence, Microsoft programs.
• BLS (Basic Life Support) certification may be required based on research study protocols or affiliate location requirements.
• CPR AED certification may be required based on research study protocols or affiliate location requirements.
• ACRP or SOCRA certification a plus.

Benefits

• PPO medical plan, available day one at no cost for full-time employee-only coverage (100% coverage for preventive healthcare—no copay).
• Paid Time Off, available day one.
• Retirement Programs through the Teacher Retirement System of Texas (TRS).
• Paid Parental Leave Benefit.
• Wellness programs.
• Tuition Reimbursement.
• Public Service Loan Forgiveness (PSLF) Qualified Employer.

Primary work location: Texas-Dallas-5323 Harry Hines Blvd.