Clinical Research Assistant Lead, Internal Medicine

The University of Texas Southwestern Medical Center; Dallas (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

UT Southwestern Medical Center in Dallas seeks a data management professional to support local and national clinical research studies. You will coordinate participant activities, ensure data quality, and maintain study documentation under PI direction.

This role emphasizes regulatory compliance, data integrity, and collaboration with research teams across departments. The position offers a comprehensive benefits package and opportunities for professional growth within a world-renowned medical

Qualifications

• Experience with managing data for complex clinical studies.
• Knowledge of regulatory requirements for human subjects research.
• Ability to coordinate participant visits and maintain study documentation.

Responsibilities

• Assists with participant screening and recruitment for complex trials or multiple research studies.
• Conducts and documents consent for participants in studies.
• Independently corrects and documents incomplete data for complex studies.
• Schedules research visits and ensures protocol adherence.
• Maintains study documents and regulatory submissions.

Skills

Data management

Clinical research

Study coordination

Regulatory knowledge

Education

High School Diploma

Associate's Degree in medical or science

Bachelor's Degree or higher in medical or science

Tools

REDCap

Excel

Databases

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 limited supervision, to provide ongoing data management for local and national research studies and may coordinate observational (non-treatment/treatment) trials/studies. Works on complex studies in a lead role, under the direction of the PI and/or Clinical Research Coordinator.

Works under the direction of Investigators and the Research program manager with limited supervision to coordinate clinical research projects. The position primarily coordinates patient participation, research visits, conduct data management and ensures the quality control of clinical research data is support of multiple drug, device or biorepository complex research studies in Pulmonary hypertension, Interstitial lung diseases, Lung transplant, Interventional Pulmonology and COPD.

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 or higher in medical or science related field
• Experience
  4 years of experience with High School Diploma or
  2 years of experience with Associate's Degree or
  1 year of experience with Bachelor's Degree or higher
  Prior experience in the UTSW clinical research mentoring program is highly desirable, and participation in the UTSW clinical research mentoring program may count as additional experience.

Preferred

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

JOB DUTIES

• Assists with participant screening and recruitment for complex trials or multiple research studies at any given time.
• Conducts and documents consent for participants in studies. Develops consent plans and documents for participants.
• Independently corrects and documents incomplete, inaccurate, or missing data for more complex studies.
• Understands visit schedules, criteria and protocol requirements for complex trials; schedules research visits, etc.
• Completes research protocol related tasks.
• Reviews and abstracts information from medical records including eligibility criteria.
• Recruits and enrolls patients in research study that may include consenting patients.
• 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.
• Assists with ordering and maintaining research supplies following university/department procedures, ensuring that equipment is in good working order.
• Assists with collecting and processing specimens following established procedures/protocols.
• 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.
• May provide working supervision or direction of lower level Clinical Research Assistants.
• 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.
• Performs other duties as assigned.

Knowledge, Skills and 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.

PHYSICAL REQUIREMENTS/WORKING CONDITIONS

Working Conditions

• Clinical Setting
• Office Setting

Salary Information

Salary is commensurate with education, skills, and relevant experience.

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.