Clinical Research Assistant II, Simmons Cancer Center

WHY UT SOUTHWESTERN?

With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report, we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career!

JOB SUMMARY

Works under the direction of an Investigator(s) with general supervision, to provide ongoing data management for local and national research studies and may coordinate observational (non-treatment/treatment) trials/studies. May provide supporting role for more complex studies under the direction of the PI, Clinical Research Coordinator and/or Clinical Research Lead. The Clinical Research Assistant II position works under the direction of the GI oncology team to enter data for our studies. The GI team maintains a complex portfolio of investigator-initiated studies, as well as NCI cooperative group studies and industry sponsored protocols. CRAs can expect to review source documents and medical records in order to enter the data generated by those records, for multiple research studies at a given time. An ideal candidate should be detail oriented and organized in order to ensure that data is entered not only timely, but accurately as well. This position is primarily a non-patient facing position, however limited patient interaction may be needed periodically.

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 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 Learn more about these and other UTSW employee benefits!

EXPERIENCE AND EDUCATION

Required Education High School Diploma or Associate's Degree in medical or science related field or Bachelor's Degree medical or science related field and no prior experience Experience 2 years experience with High School Diploma or 1 year experience with Associate's Degree Preferred Licenses and Certifications

• BLS) BASIC LIFE SUPPORT may be required based on affiliate location requirements.
• CPRAED) CPR AED may be required based on affiliate location requirements.

JOB DUTIES

Understands visit schedules, criteria and protocol requirements for low complexity trials (e.g., questionnaire, data registry, scripted); schedules research visits. Assists research staff by completing research protocol related tasks. Reviews and abstracts information from medical records including eligibility criteria. Enters data into case report forms or other data collection system based on research study. Assists with maintenance of study level documentation. Assists with data queries and possible edits for accuracy. Compiles data for regulatory requirements and /or deadlines for local or sponsor submissions. Maintains existing databases and ensures data integrity. Performs QA/QC clinical analysis and data checks using various databases based on trial. Assists with preparing annual reports and/or modifications to institutional review board (IRB). This may include reportable events (UPIRSO). Assist and prepare research records for formal sponsor audits or internal audits. Recruits and enrolls patients in research study that may include consenting patients after training and with supervision. With adequate training and supervision, assists with participant screening and recruitment for more complex trials. Conducts and documents consent for participants in studies. Assists with the development of consent plans and documents for participants. Identifies incomplete, inaccurate, or missing data for more complex studies and works with lead coordinator to correct errors. Assists with ordering and maintaining research supplies following university/department procedures, ensuring that equipment is in good working order. With adequate training and supervision, assists with collecting and processing specimens following established procedures/protocols. Assists in preparing studies for closeout, (e.g. packing files, documenting files for storage, shipping extra supplies back to sponsor). With adequate training/credentialing and supervision, performs study procedures such as phlebotomy, vital signs, and EKG's needed for research study. Based on research study, other procedures/equipment/services may be required. May perform patient care (basic skills) under the direction of PI following scope of work document. 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. University Of Texas Southwestern Medical Cent (The)