Clinical Research Assistant I

The University of Texas Southwestern Medical Center; Dallas (TX); On-site; USD 46,000 - 65,000; Full time

Job summary

The University of Texas Southwestern Medical Center in Dallas is seeking a Clinical Research Assistant I to support data management for local and national studies under supervision. Key tasks include participant screening, recruitment, data entry, and obtaining informed consent, with responsibilities for study documentation, regulatory deadlines, and collaboration with study teams.

This entry-level position emphasizes accuracy, protocol understanding, and collaboration within a clinical research

Qualifications

• Experience with data entry and data management for research studies.
• Ability to understand visit schedules, inclusion/exclusion criteria and protocol requirements.
• Recruitment and enrollment of research participants.

Responsibilities

• Enter data into case report forms and maintain study documentation.
• Assist with data queries and edits for accuracy.
• Compile data for regulatory requirements and sponsor submissions.
• Maintain existing databases and ensure data integrity.
• Understand visit schedules, criteria and protocol requirements for routine and low complexity trials; schedule research visits.
• Assist with preparing annual reports and IRB modifications.

Job description

Job Description - Clinical Research Assistant I (968332)

Job Description

Clinical Research Assistant I - ( 968332 )

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 primarily provide ongoing data management for local and national research studies. May coordinate observational (non-treatment) studies.

This position will assist with participant screening, recruitment, data entry, and document consent. The candidate will need to be able to understand the scheduled visits, inclusion/exclusion criteria and protocol requirements required for each of the studies. The incumbent will assist with the study level documentation and compile data for regulatory requirements/deadlines for local and sponsor submissions.

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
• 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
• 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.

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.

UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. In accordance with federal and state law, the University prohibits unlawful discrimination, including harassment, on the basis of: race; color; religion; national origin; gender, including sexual harassment; age; disability; citizenship; and veteran status. In addition, it is UT Southwestern policy to prohibit discrimination on the basis of sexual orientation, gender identity, or gender expression.