Clinical Research Assistant II, ObGyn

The University of Texas Southwestern Medical Center; Dallas (TX); On-site; USD 45,000 - 65,000; Full time

Benefits offered by this job

PPO medical plan

Preventive care coverage

Paid Time Off

TRS retirement programs

Paid parental leave

Wellness programs

Tuition reimbursement

PSLF-qualified employer

Job summary

UT Southwestern Medical Center in Dallas seeks a Clinical Research Assistant II to support multiple clinical studies under supervision. Responsibilities include recruiting, screening, enrolling, coordinating visits, and handling data via CRFs, EPIC, and QA/QC to ensure protocol adherence.

The role collaborates with investigators, coordinators, and nurses, supporting start-up, maintenance, and closeout activities, and assisting with regulatory submissions while maintaining data integrity.

Qualifications

• Education and experience requirements as stated in the job posting.
• Ability to perform data entry, manage visits, and maintain study records.

Responsibilities

• Supports multiple clinical studies under supervision.
• Recruits, screens, consents, enrolls participants and coordinates visits.
• Explains study procedures and collects data via CRFs and EPIC.
• Performs data quality reviews and resolves queries.
• Assists with regulatory documentation and IRB-related tasks.
• Maintains databases and data integrity for study files.
• May assist with biospecimen handling and shipping.
• Supports study start-up, maintenance, and closeout activities.

Education

Education: High School Diploma or Associate's Degree or Bachelor's Degree in medical/science

Experience: 2 years with HS Diploma or 1 year with AA

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.

The Clinical Research Assistant II will independently and collaboratively support multiple clinical studies by recruiting, screening, consenting, enrolling, and following participants; coordinating study visits; explaining study procedures; collecting and 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 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

• 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 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.