Clinical Research Assistant II, Harold C. Simmons Comprehensive Cancer Center - Tissue Core

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. As the only National Cancer Institute-designated comprehensive cancer center in North Texas, we invite you to continue your healthcare career with us at Harold C. Simmons Comprehensive Cancer Center. You’ll discover a magnet facility with a culture of teamwork, professionalism, and consistent opportunities for learning and advancement into leadership roles.

Job Summary

Our core facility collects human biospecimens which are used by faculty on campus for their research. The Clinical Research Assistant II is responsible for collecting biospecimens at various clinics and hospitals (UTSW and Parkland). In this role, you will be the key coordinator for identifying and procuring human specimens for multiple research colorectal cancer translational research projects. You will also be the primary personnel for managing a non-interventional clinical study that just opened for accrual. Candidates who are bilingual in Spanish and English highly preferred. 

Experience and Education

Minimum Requirements

• High School and 2 years of experience. OR
• Associate’s degree in medical or science related field and 1 year of experience. OR
• Bachelor’s degree in medical or science related field and no prior experience.
• A minimum of Heart Saver for non-licensure or BLS for Licensure may be required based on affiliate location requirements. 

Job Duties

May perform some or all of the following based on research study:

• Understands visit schedules, inclusion/exclusion 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. 

Knowledge, Skills & Abilities

Knowledge of applicable Federal and institutional regulations governing clinical research. Knowledge of clinical research protocols. Effective organizational skills and attention to detail. Proactively works to maximize results of the team and organization. Follows and understands the regulations for Protected Health Information (PHI). Proactively works to maximize results of the team and organization. Possess strong computer skills (spreadsheets, databases, and interactive web-based software). Possess good communication skills. Possess the ability to problem solve. Work requires ability to conduct interviews with research subjects.

Working Conditions

Work is performed primarily in an office environment but may require periodic visits to clinical and off-site clinical areas for purpose of interviewing patients. May require local or out-of-state travel based on research study. 

Compliance with the COVID-19 vaccine mandate enforced by the Centers for Medicare and Medicaid (CMS) is a requirement for this position. Federal law requires individuals holding this position to be fully vaccinated or have an approved exemption for certain medical, disability, or religious reasons. Individuals who do not meet CMS vaccination requirements are not eligible and should not apply for this position but are encouraged to apply for other non-healthcare positions at UT Southwestern for which they qualify.

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.