Clinical Research Assistant I, Internal Medicine

University of Texas Southwestern Medical Center; Dallas (TX); On-site; USD 48,000 - 64,000; Full time

Benefits offered by this job

Parental leave

Paid time off

Paid holidays

Tuition reimbursement

On-site childcare

Job summary

UT Southwestern Medical Center in Dallas seeks a Clinical Research Assistant I in Internal Medicine to support multiple studies through data management, participant recruitment, and coordination with investigators.

The role involves data entry in CRFs and EPIC, QA, and assistance with study start-up and closeout, with emphasis on protocol compliance and regulatory documentation.

Qualifications

• High School Diploma or GED required.
• BLS/CPR AED may be required based on study protocols.

Responsibilities

• Enters data into case report forms or other data collection system.
• Assists with data queries and edits for accuracy.
• Compiles data for regulatory requirements and sponsor submissions.
• Maintains existing databases and ensures data integrity.
• Schedules research visits and understands study criteria and protocol requirements.
• Assists with preparing annual reports and IRB modifications as needed.
• Reviews medical records for eligibility criteria.
• Recruits and enrolls patients in research studies.
• Maintains and orders research supplies; ensures equipment is operational.
• Collects and processes specimens following established procedures.

Skills

Data management

Data entry

PHI compliance

Communication skills

Interviews

Education

High School Diploma or GED

Tools

EPIC

Excel

CRFs

Job description

Clinical Research Assistant I, Internal Medicine

parental leave, paid time off, paid holidays, tuition reimbursement

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 e r the d irection 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
• 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 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.

Knowledge, Skills and Abilities

• Possess strong computer skills (spreadsheets, databases, and interactive web-based software).
• Follows and understands the regulations for Protected Health Information (PHI).
• Proactively works to maximize results of the team and organization.
• 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.