Clinical Research Assistant II, Simmons Cancer Center

UTSW; Texas; On-site; USD 45,000 - 65,000; Full time

Benefits offered by this job

PPO medical plan

Paid Time Off

Retirement programs (TRS)

Paid parental leave

Wellness programs

Tuition reimbursement

PSLF Qualified Employer

Job summary

UT Southwestern Medical Center is seeking a Clinical Research Assistant II to support oncology trials within the Simmons Comprehensive Cancer Center. You will coordinate visits, review eligibility, and manage data under supervision, aiding PI-directed studies and patient care throughout the trial continuum.

The role involves assisting with consent, data entry, and regulatory tasks, with opportunities to contribute to multi-disease precision oncology initiatives and IRB-related activities.

Qualifications

• Clinical research knowledge and data handling skills.
• Experience coordinating observational or interventional studies.
• Familiarity with IRB processes and regulatory requirements.

Responsibilities

• Understand visit schedules and protocol requirements for low-complexity trials.
• Enter data into case report forms and maintain study documentation.
• Review medical records for eligibility criteria and coordinate visits.
• Recruit and enroll patients and assist with consent processes.
• Support audits and regulatory submissions as needed.

Skills

Clinical Research

Data Management

Study Coordination

IRB Knowledge

Education

Bachelor's Degree (science/medical)

Associate's Degree

High School Diploma

Tools

EDC

IRB Systems

Job description

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 Simmons Comprehensive Cancer Center is seeking a Clinical Research Assistant II. This position will manage complex clinical oncology trials in the Multi-Disease Precision Oncology (MPOP) Disease Oriented Team (DOT) Program This role interfaces with physicians and patients seeking to participate in treatment trials for their cancer. CRCs review eligibility for prospective patients, schedule procedures and tests in accordance with the IRB approved protocol, participate in the consent process with the study patient and continues to coordinate the activities related to the clinical trials for that patient all the way through their continuum of care while on study.

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.