Clinical Research Assistant II, Surgical Sciences

UT Southwestern Medical Center • Dallas, TX

17h

About The Position

The Department of Surgery is seeking a highly motivated and detail‑oriented individual to serve as the primary coordinator for a diverse portfolio of human subject research studies, including FDA-regulated clinical trials involving investigational drugs and medical devices seeking market approval.
The Clinical Research Assistant II (CRA II) will be responsible for coordinating assigned clinical trials and research studies as delegated by the faculty investigator and department leadership. This role requires strong organizational skills, sounds professional judgment, and the ability to ensure compliance with regulatory requirements and study protocols.
This position is well‑suited for candidates with a strong background in biomedical sciences and prior patient-facing healthcare experience. It is also an excellent opportunity for individuals seeking to gain additional clinical research exposure before applying to graduate‑level medical or healthcare professional programs.

Requirements

• 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
• 2 years experience with High School Diploma or
• 1 year experience with Associate's Degree

Nice To Haves

• (BLS) BASIC LIFE SUPPORT may be required based on affiliate location requirements.
• (CPRAED) CPR AED may be required based 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 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.

Benefits

• PPO medical plan, available day one at no cost for full-time employee-only coverage
• 100%25 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree