Clinical Research Assistant II

Location

Type, TX | United States

Job description

Clinical Research Assistant II, Radiological Sciences 

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 #1 hospital in Dallas-Fort Worth for the fifth consecutive year, we invite you to continue your healthcare career with us at William P. Clements Jr. University Hospital. You’ll discover a culture of teamwork, professionalism, and consistent opportunities for learning and advancement into leadership roles.

Job Summary

The Radiology Clinical Research Office is responsible for managing an ever-growing number of active clinical trials in the department. Faculty members in the department rely on study coordinators to manage the day to day operations for these trials and ensure compliance with local and federal policy. This position is needed to support the ongoing clinical trials and research studies as well as new projects proposed by faculty.  This Clinical Research Assistant II will server the Radiology Clinical Research Office by conducting the daily operations of radiology research projects. This coordinator will be responsible for multiple aspects of numerous clinical trials including recruitment of research subjects, scheduling and conduct of research visits, maintenance of study records, study documentation, data submission, regulatory submissions, etc. A successful candidate will have excellent organizational and communication skills and be comfortable with patient contact. 

This Clinical Research Assistant II will serve the Radiology Clinical Research Office by conducting the daily operations of radiology research projects. This coordinator will be responsible for multiple aspects of numerous clinical trials including recruitment of research subjects, scheduling and conduct of research visits, maintenance of study records, study documentation, data submission, regulatory submissions, etc.  They will work 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. They may provide supporting role for more complex studies under the direction of the PI, Clinical Research Coordinator and/or Clinical Research Assistant Lead.

Experience and Education

• High School and 2 years of experience, Associate’s degree in medical or science related field and 1 year of experience, or Bachelor’s degree in medical or science related field and no prior experience. 
• A minimum of Heart Saver for non-licensure or BLS for Licensure may be required based on affiliate location requirements.  

Job Duties

• May perform some or all of the following based on research study: Understands visit schedules, inclusion/exclusion 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: 
  • Directly interacting with or caring for patients;
  • Directly interacting with or caring for human-subjects research participants;
  • Regularly maintaining, modifying, releasing or similarly affecting patient records (including patient financial records);
  • Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records.
• Performs other duties as assigned.    

Knowledge, Skills & Abilities

• 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.    

Working Conditions

• Work is performed primarily in an office environment but may require periodic visits to clinical and off-site clinical areas for purpose of interviewing patients. 
• May require local or out-of-state travel based on research study.  

Security

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.  To learn more, please visit:    

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