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Job Summary 

 The Pediatrics Department is currently seeking a qualified candidate to fill the role of Clinical Research Coordinator I within the Pediatrics Research Administration team. In this position, the primary responsibilities entail patient/participant coordination and proficient management of research data. The ideal candidate will play a pivotal role in the collection and meticulous quality control of clinical or basic research data, providing invaluable support to intricate research studies. The successful applicant will demonstrate exceptional attention to detail and possess the capability to navigate complex research protocols effectively

 Experience and Education

• Bachelor’s or higher degree in medical or science related field and one-year clinical research experience.
• May consider additional years of experience or advanced degree in lieu of education or experience, respectively. ACRP or SOCRA certification a plus.
•  A Heart Saver for non-licensure or BLS for Licensure may be required based on research study protocols or affiliate location requirements.

Job Duties

 May perform some or all the following:

• 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.

Knowledge, Skills & Abilities

• Work requires knowledge of basic and clinical research terminology, regulations, and procedures.
• Work requires strong computer skills (spreadsheets, databases, and interactive web-based software).
• Work requires ability to communicate effectively with various levels of internal and external contacts.
• Work requires ability to work with confidential information on daily basis
• Proactively works to maximize results of the team and organization
• Follows and understands the regulations for Protected Health Information (PHI)
• Work requires good communication skills.
• Work requires the ability to problem solve.

Working Conditions

•  Work is performed primarily in office environment but may require periodic visits to clinic areas for purpose of interviewing patients.

This position is security-sensitive and subject to Texas Education Code §51.215, which authorizes UT Southwestern to obtain criminal history record information. 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. To learn more, please visit: https://jobs.utsouthwestern.edu/why-work-here/diversity-inclusion