Clinical Research Assistant II, ObGyn

About the role

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, ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report, we invest in employees with opportunities for career growth and development.

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.

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), including 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 EKGs 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

Requirements

• High School Diploma with 2 years experience, OR Associate's Degree in medical or science related field with 1 year experience, OR Bachelor's Degree in medical or science related field with no prior experience

Qualifications

• Basic Life Support (BLS) may be required based on affiliate location requirements
• CPR AED may be required based on affiliate location requirements

Benefits

• 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

Schedule

Full-time, Day shift

Primary location: 5323 Harry Hines Blvd, Dallas, Texas. Organization: OB-Uro Pelv Recon Surg (418008).