Clinical Research Assistant II

UT Southwestern Medical Center; Dallas (TX); On-site; USD 52,000 - 82,000; Full time

Benefits offered by this job

PPO health plan

Paid time off

TRS retirement

Parental leave

Wellness programs

Tuition reimbursement

PSLF eligibility

Job summary

UT Southwestern Medical Center is seeking a data management professional to support local and national research studies. The role involves coordinating observational trials, maintaining data integrity, and assisting with regulatory documentation under supervision.

Responsibilities include data entry, eligibility screening, and preparation of study records. A background in medical or science fields and some clinical research experience are preferred.

Qualifications

• Experience in data entry and data integrity checks.
• Familiarity with clinical research processes and study protocols.
• Ability to review records and abstract information for studies.

Responsibilities

• Understand visit schedules, criteria and protocol requirements for trials.
• Assist research staff with protocol related tasks and data entry.
• Review medical records for eligibility criteria.
• Enter data into case report forms and maintain study documentation.
• Support data queries, audits, and regulatory submissions.
• Maintain databases and ensure data integrity.
• Assist with QA/QC checks and study closeout activities.
• Support recruitment and consent processes under supervision.

Skills

Data management

Research coordination

Education

High School Diploma

Associate's Degree in medical or science related field

Bachelor's Degree in medical or science related field

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.

BENEFITS

• 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 re