Clinical Research Coordinator I, Simmons Cancer Center

• 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.