Clinical Research Coordinator I - Float, Pediatrics

WHY UT SOUTHWESTERN?
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. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career!

JOB SUMMARY
Works under the direction of an Investigator(s) with general supervision, to coordinate research projects. This position primarily performs patient/participant coordination, however, may conduct data management in smaller departments on as needed basis. Collects and ensures quality control of clinical or basic research data in support of multiple and/or complex research studies.

The Clinical Research Coordinator I Float will provide Coverage Support (Pl-Funded): Subject scheduling and visit coordination. Data entry and query resolution. Sponsor communication and monitoring visit coordination. Protocol adherence and documentation maintenance. Regulatory Start-Up Support (Start-Up Funded): IRB submissions and amendments. Regulatory document preparation and maintenance (e.g., delegation logs, training documentation). Contract and budget start-up coordination support (in collaboration with research administration). Facilitation of study activation workflows.

BENEFITS
UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include:

• 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
• Learn more about these and other UTSW employee benefits!

EXPERIENCE AND EDUCATION

Required

• Education
  Bachelor's Degree or higher degree in medical or science related field
  

• Experience
  1 year of clinical research experience
  May consider additional years of experience or advanced degree in lieu of education or experience, respectively.
  

Preferred

• Licenses and Certifications
  (BLS) BASIC LIFE SUPPORT Licensure may be required based on research study protocols or affiliate location requirements.
  (CPRAED) CPR AED Licensure may be required based on research study protocols or affiliate location requirements.
  ACRP or SOCRA certification a plus

  Core soft skills (highly preferred)
  • Strong written and verbal communication skills for interaction with patients, families, and clinical teams
  • Compassionate, professional demeanor when working with children and caregivers in stressful or acute settings
  • Ability to build rapport and maintain positive working relationships with multidisciplinary staff
  • High level of attention to detail and accuracy in data entry and documentation
  • Strong organizational skills with the ability to manage multiple tasks in a fast-paced environment
  • Dependability and flexibility, including willingness to work evenings/weekends as study needs require
  • Critical thinking and problem-solving skills when screening participants or addressing study-related issues
  • Comfort working in an emergency department environment
  • Ability to maintain confidentiality and handle sensitive information appropriately

  Preferred qualifications/experience
  • Prior experience in clinical research or healthcare setting (e.g., research assistant, scribe, MA, CNA, EMT, volunteer experience)
  • Experience working with pediatric populations
  • Experience collecting data in clinical settings or using electronic data capture systems (e.g., REDCap)
  • Familiarity with IRB processes, consenting, or human subjects protections
  • Knowledge of Good Clinical Practice (GCP) or completion of CITI training (or willingness to complete upon hire)
  • Experience with Microsoft Office, particularly Excel and Outlook; comfort navigating databases
  • Experience with participant recruitment, screening, or retention activities
  • Bilingual (English/Spanish) preferred but not required

• Strong clinical research regulatory experience in an academic medical center or clinical research site environment
• Demonstrated experience preparing and submitting IRB applications, amendments, continuing reviews, and reportable events in accordance with institutional and federal requirements.
• Experience supporting study start-up activities, prepare and submit initial IRB packages and regulatory documentation required for study activation
• Coordinate with sponsors, CROs, and institutional departments to ensure timely study start-up and site activation.
• Support development of study documents including consent forms, recruitment materials, and protocol-specific regulatory submissions
  
  General responsibilities experience preferred
  • Assisting with informed consent or assent processes
  • Data entry and data quality review
  • Chart review or medical record abstraction
  • Participant scheduling and communication
  • Assisting research coordinators with study visits and logistics
  • Maintaining study files and documentation
  
  

JOB DUTIES

• Directly interacts with clinical research participants, as required, for the research study. Interacts via telephone, telehealth or in-person.
• Coordinate regulatory aspects of the trial including maintaining and developing regulatory information to comply with industry standards, University policies, FDA requirements or other hospital policies
• Coordinate and schedule study procedures as per protocol. Approved study protocols which have order sets built may be pended by the non-licensed coordinator with oversight by PI.
• When outside of protocol, presents evidence and provides options (within scope of protocol) to PI.
• Screen, recruit, enroll and follow subjects according to protocol guidelines. May also assist with the consent process
• Maintain and coordinate data collection information required for each study which may also include developing CRF's or data collection tools
• Assist in developing and implementing research studies to include writing clinical research protocols.
• Conduct study procedures according to the protocol with proper training and check offs to maintain scope of work
• Requires familiarity with research budgets to assist with or develop study budgets. May perform research billing activities, as needed, based on size of department (including linking patient calendars).
• May review and abstract information from medical records for verification of eligibility for trials, as needed based on size of department.
• Monitors patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards.
• Review research study protocols to ensure feasibility
• Assist in developing website or other social media for marketing/recruiting of clinical research study
• Develop proficiency in the clinical trial management system, electronic medical record and other required data entry systems
• Maintain subject level documentation
• Duties performed may include one or more of the following core functions: a) Directly interacting with or caring for patients; b) Directly interacting with or caring for human-subjects research participants; c) Regularly maintaining, modifying, releasing or similarly affecting patient records (including patient financial records); or d) Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records.
• Performs other duties as assigned.

SECURITY AND EEO STATEMENT

Security
This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.

EEO
UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status.