Clinical Research Assistant II
UT Southwestern
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Job summary
UT Southwestern Medical Center in Dallas, TX is seeking a Clinical Research Assistant to support local and national studies. You will coordinate participant visits, collect data, and assist with regulatory tasks under supervision within a multidisciplinary research team.
The role involves handling data entry, coordinating with PI and coordinators, and performing basic procedures like phlebotomy with training.
Qualifications
- Education: High School Diploma or Associate's Degree in medical or science related field or Bachelor's Degree in medical or science related field
- Experience: 2 years with High School Diploma or 1 year with Associate's Degree
- Preferred: BLS CPR AED may be required depending on affiliate location requirements
Responsibilities
- Coordinate participant visits per study protocol and visit schedule.
- Enter data into case report forms and maintain study documentation.
- Assist with preparing regulatory submissions and IRB documentation.
- Support coordination with Radiology, Neurosurgery and Psychiatry teams.
Skills
Education
Tools
Job description
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
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 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!
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. Assist in coordination of the study for the Raynor Cerebellum Project, investigating brain circuit novel brain stimulation therapeutics for individuals with cerebellar disorders. The Clinical Research Assistant will collaborate with a large team of research coordinators across Radiology, Neurosurgery and Psychiatry departments.
- Participant coordination, recruitment, screening, and scheduling.
- Experimental design & implementation, conducting behavioral studies with research participants and collecting physiological data from patients with deep brain stimulator implants
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!
- 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
- 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.
- 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.
- Knowledge of applicable Federal and institutional regulations governing clinical research.
- Knowledge of clinical research protocols.
- Effective organizational skills and attention to detail.
- Proactively works to maximize results of the team and organization.
- Follows and understands the regulations for Protected Health Information (PHI).
- Proactively works to maximize results of the team and organization.
- Possess strong computer skills (spreadsheets, databases, and interactive web-based software).
- Possess good communication skills.
- Possess the ability to problem solve.
- Work requires ability to conduct interviews with research subjects.
- Clinical Setting
- Office Setting
Salary Is Commensurate With Education, Skills, And Relevant Experience.
This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.
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.
Texas-Dallas-5323 Harry Hines Blvd
5323 Harry Hines Blvd
Research & Laboratory
416000 - NS-Department Administration
Full-time
Day Job
Standard
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