Clinical Research Assistant I, Internal Medicine

UT Southwestern Medical Center; Dallas (TX); On-site; USD 42,000 - 56,000; Full time

Benefits offered by this job

PPO medical plan

Paid Time Off

Retirement Programs

Paid Parental Leave

Wellness programs

Tuition Reimbursement

Public Service Loan Forgiveness (PSLF)

Job summary

UT Southwestern Medical Center is seeking a Clinical Research Assistant I to support ongoing local and national studies through data management, data entry, and coordination with study teams.

The role involves assisting with recruitment, screening, and participant follow-up, as well as maintaining data quality and regulatory documentation under supervision.

Qualifications

• Experience with data management for research is preferred.
• Ability to perform data quality reviews and resolve queries.
• Familiarity with case report forms and data capture systems.

Responsibilities

• Enter data into case report forms or data collection systems per protocol.
• Assist with data queries and edits for accuracy.
• Support regulatory submissions and IRB documentation.
• Maintain study databases and ensure data integrity.
• Assist with specimen processing and shipping as needed.

Skills

Data management

Data entry

Regulatory submissions

Education

High School Diploma or GED

Tools

EPIC

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 No. 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 primarily provide ongoing data management for local and national research studies. May coordinate observational (non-treatment) studies.

Wor k s und ection of an Investigator(s) with g eneral sup e rvisio n , to prim a rily provi d e ong o ing data management f o r loc a l an d n ation a l r e se a rch st u di e s. May assist with interventional and observational (non-tre a tment) stu d ies (two or more) as needed, providing support for more complex studies under the direction of the PI or Clinical Research Coordinator.

The Clinical Research Assistant I will independently and collaboratively support multiple clinical studies by assisting with recruitment, screening, consenting, and following participants; managing research data through CRFs, electronic data capture systems, and EPIC; supporting laboratory activities including specimen processing and shipping; performing data quality reviews and query resolution; ensuring protocol compliance; assisting with study start-up, maintenance, and closeout activities; and providing operational support to the Clinical Research Coordinators and Research Nurses.

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

• EducationHigh School Diploma or GED

Preferred

• Licenses and Certifications(BLS) BASIC LIFE SUPPORT may be required based on research study protocols or affiliate location requirements.
• (CPRAED) CPR AED may be required based on affiliate location requirements

JOB DUTIES

• 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.
• Understands visit schedules, criteria and protocol requirements for routine and low complexity trials (e.g., questionnaire, data registry, scripted); schedules research visits.
• Assists research staff by completing research protocol related tasks.
• Assists with preparing annual reports and/or modifications to institutional review board (IRB). This may include reportable events (UPIRSO).
• Reviews and abstracts information from medical records including eligibility criteria.
• Recruits and enrolls patients in research study that may include consenting patients after training and with supervision.
• 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.
• 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.