Clinical Research Coordinator I, Pediatrics Cystic Fibrosis

UT Southwestern Medical Center • Dallas, TX

9d • Onsite

About The Position

This position works under the direction of an Investigator(s) with general supervision to coordinate research projects. The primary focus is patient/participant coordination, with potential for data management in smaller departments as needed. The role involves collecting and ensuring quality control of clinical or basic research data for multiple and/or complex studies. Responsibilities include maintaining databases, completing data abstraction and queries, utilizing the ECRF platform, preparing for study visits, screening patients for eligibility, supporting the CF plus team in building RedCap projects, and ensuring study compliance with all regulatory requirements.

Requirements

• Bachelor's Degree or higher degree in a medical or science-related field.
• 1 year of clinical research experience.
• May consider additional years of experience or advanced degree in lieu of education or experience, respectively.

Nice To Haves

• BLS (Basic Life Support) Licensure may be required based on research study protocols or affiliate location requirements.
• CPR AED Licensure may be required based on research study protocols or affiliate location requirements.
• ACRP or SOCRA certification is a plus.

Responsibilities

• Directly interacts with clinical research participants 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.
• Pends approved study protocols with order sets built by the non-licensed coordinator with oversight by PI.
• Presents evidence and provides options (within scope of protocol) to PI when outside of protocol.
• Screen, recruit, enroll, and follow subjects according to protocol guidelines.
• Assist with the consent process.
• Maintain and coordinate data collection information required for each study, which may include developing CRF's or data collection tools.
• Assist in developing and implementing research studies, including writing clinical research protocols.
• Conduct study procedures according to the protocol with proper training and check-offs.
• Assist with or develop study budgets and perform research billing activities as needed.
• Review and abstract information from medical records for verification of eligibility for trials.
• Monitor patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards.
• Review research study protocols to ensure feasibility.
• Assist in developing websites or other social media for marketing/recruiting of clinical research studies.
• Develop proficiency in the clinical trial management system, electronic medical record, and other required data entry systems.
• Maintain subject-level documentation.
• Perform duties that 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level