Clinical Research Coordinator I

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.

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
• Retail Programs through the Teacher Retirement System of Texas (TRS)
• Paid Parental Leave
• Wellness programs
• Tuition Reimbursement
• Public Service Loan Forgiveness (PSLF)

Required EXPERIENCE AND EDUCATION

• 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: ACRP or SOCRA certification a plus

Job Duties

• Directly interacts with clinical research participants, as required, for the research study. Interacts via telephone, telehealth or in-person.
• Carefully coordinates regulatory aspects of the trial including maintaining and developing regulatory information to comply with industry standards, University policies, FDA requirements or other hospital policies.
• Carefully schedules 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.
• Screens, recruits, enrolls and follows subjects according to protocol guidelines. May also assist with the consent process.
• Maintains and coordinates data collection information required for each study which may also include developing CRF's or data collection tools.
• Aids in developing and implementing research studies to include writing clinical research protocols.
• Conducts 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).
• Reviews and abstracts information from medical records for verification of eligibility for trials, as needed based on size of department.
• Maintains patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards. Reviews research study protocols to ensure feasibility.
• Develops proficiency in the clinical trial management system, electronic medical record and other required data entry systems.
• Maintains subject level documentation.

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);
• Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records.

Security and EEO Statement

• 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.