Clinical Research Coordinator I, Pediatric Emergency Medicine Research

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Job Summary

 This position will support a number of clinical trials and studies in the Pediatric ER division. The CRC will provide study-related services ranging from IRB submission, regulatory document preparation, participant recruitment, consenting, coordinating and conducting study visits, answering queries, creating databases, completing source documents and case report forms, and data entry. This individual must have prior clinical trials experience – specific experience with pediatric populations and clinical trials is preferred.

 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.

 To learn more about the benefits UT Southwestern offers visit https://www.utsouthwestern.edu/employees/hr-resources/

 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.