ObGyn Clinical Research Specialist II

UT Southwestern Medical Center; Dallas (TX); On-site; USD 52,000 - 66,000; Full time

Job summary

UT Southwestern Medical Center in Dallas, TX seeks a Clinical Research Assistant II to provide ongoing data management for local and national studies. You will recruit, screen, consent, enroll and follow participants, coordinate visits, and ensure protocol compliance across multiple studies.

The role involves data capture in CRFs and EPIC, sample handling, QA/QC checks, and assisting with study start-up, maintenance and closeout. Training and supervision provided for more complex tasks.

Qualifications

• High School Diploma or an Associate's Degree in a medical or science related field.
• Bachelor's Degree in medical or science related field with no prior experience also acceptable.
• Professional certifications such as BLS/CPR may be required depending on affiliate location requirements.

Responsibilities

• 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/credentialing and supervision, performs study procedures such as phlebotomy, vital signs, and EKG's needed for research.

Education

High School Diploma

Associate's Degree in medical or science related field

Bachelor's Degree in medical or science related field and no prior experience

Tools

EPIC

Job description

UT Southwestern Medical Center in Dallas, TX seeks a Clinical Research Assistant II to provide ongoing data management for local and national studies. You will recruit, screen, consent, enroll and follow participants, coordinate visits, and ensure protocol compliance across multiple studies.

The role involves data capture in CRFs and EPIC, sample handling, QA/QC checks, and assisting with study start-up, maintenance and closeout. Training and supervision provided for more complex tasks.