What are the responsibilities and job description for the Clinical Research Assistant I, Pediatrics position at UT Southwestern?
Why UT Southwestern?
With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. At UT Southwestern, we invest in you with opportunities for career growth and development that align with your future goals and help to provide security for you and your family. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more that are all available on the day you start work. UT Southwestern is honored to be a Veteran Friendly work environment that is home to approximately 800 veterans. We value your integrity, dedication, and the commitment you’ve made to our country. We’re proud to support your next mission. Ranked by Forbes as one of the Top 10 National Employers, we invite you to be a part of the UT Southwestern team where you’ll discover teamwork, professionalism, and consistent opportunities for growth.
Job Summary
This position will support several clinical trials and studies in the Pediatric ER division. The CRA I will provide a range of study-related services, including participant recruitment, consenting, coordinating, answering queries, completing source documents and case report forms, and data entry. Prior clinical trials experience is required, with a preference for those who have experience with pediatric populations and clinical trials.
Experience and Education
High School diploma or GED with no experience.
A minimum of Heart Saver for non-licensure or BLS for Licensure may be required based on research study protocols or affiliate location requirements.
Job Duties
May perform some or all the following based on research study:
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.
Understands visit schedules, inclusion/exclusion criteria and protocol requirements for routine and low complexity trials (e.g., questionnaire, data registry, scripted); schedules research visits.
Assists research staff by completing research protocol related tasks.
Assists with preparing annual reports and/or modifications to institutional review board (IRB).
This may include reportable events (UPIRSO).
Reviews and abstracts information from medical records including eligibility criteria.
Recruits and enrolls patients in research study that may include consenting patients after training and with supervision.
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.
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, Skills & Abilities
Possess strong computer skills (spreadsheets, databases, and interactive web-based software).
Follows and understands the regulations for Protected Health Information (PHI).
Proactively works to maximize results of the team and organization.
Possess good communication skills.
Possess the ability to problem solve.
Work requires the 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.
To learn more about the benefits UT Southwestern offers visit https://www.utsouthwestern.edu/employees/hr-resources/
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. Benefits 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!
With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. At UT Southwestern, we invest in you with opportunities for career growth and development that align with your future goals and help to provide security for you and your family. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more that are all available on the day you start work. UT Southwestern is honored to be a Veteran Friendly work environment that is home to approximately 800 veterans. We value your integrity, dedication, and the commitment you’ve made to our country. We’re proud to support your next mission. Ranked by Forbes as one of the Top 10 National Employers, we invite you to be a part of the UT Southwestern team where you’ll discover teamwork, professionalism, and consistent opportunities for growth.
Job Summary
This position will support several clinical trials and studies in the Pediatric ER division. The CRA I will provide a range of study-related services, including participant recruitment, consenting, coordinating, answering queries, completing source documents and case report forms, and data entry. Prior clinical trials experience is required, with a preference for those who have experience with pediatric populations and clinical trials.
Experience and Education
High School diploma or GED with no experience.
A minimum of Heart Saver for non-licensure or BLS for Licensure may be required based on research study protocols or affiliate location requirements.
Job Duties
May perform some or all the following based on research study:
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.
Understands visit schedules, inclusion/exclusion criteria and protocol requirements for routine and low complexity trials (e.g., questionnaire, data registry, scripted); schedules research visits.
Assists research staff by completing research protocol related tasks.
Assists with preparing annual reports and/or modifications to institutional review board (IRB).
This may include reportable events (UPIRSO).
Reviews and abstracts information from medical records including eligibility criteria.
Recruits and enrolls patients in research study that may include consenting patients after training and with supervision.
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.
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, Skills & Abilities
Possess strong computer skills (spreadsheets, databases, and interactive web-based software).
Follows and understands the regulations for Protected Health Information (PHI).
Proactively works to maximize results of the team and organization.
Possess good communication skills.
Possess the ability to problem solve.
Work requires the 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.
To learn more about the benefits UT Southwestern offers visit https://www.utsouthwestern.edu/employees/hr-resources/
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. Benefits 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!
