Clinical Research Assistant II - Pediatric Neurology

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 No. 1 hospital in Dallas-Fort Worth according to 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! 

JOB SUMMARY
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. 

This CRA II position in the Department of Pediatrics, supporting the division of Neurology, will primarily support investigator-initiated studies, including natural history studies and a biorepository. Primary duties will include patient recruitment, consenting, data collection, data entry, biospecimen collection and processing, query resolution, and overall regulatory management. Experience with REDCap strongly preferred but not required. This position will be part of a collaborative team environment.

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!

EXPERIENCE AND EDUCATION

Required

• 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 
   

Preferred

• 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. 
   

JOB DUTIES

• 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, Skills and 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.

PHYSICAL REQUIREMENTS/WORKING CONDITIONS

Working Conditions

• Clinical Setting
• Office Setting

Salary Information
Salary is commensurate with education, skills, and relevant experience.

SECURITY AND EEO STATEMENT

Security
This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.

EEO
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.
 

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 No. 1 hospital in Dallas-Fort Worth according to 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! 

JOB SUMMARY
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. 

This CRA II position in the Department of Pediatrics, supporting the division of Neurology, will primarily support investigator-initiated studies, including natural history studies and a biorepository. Primary duties will include patient recruitment, consenting, data collection, data entry, biospecimen collection and processing, query resolution, and overall regulatory management. Experience with REDCap strongly preferred but not required. This position will be part of a collaborative team environment.

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!

EXPERIENCE AND EDUCATION

Required

• 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 
   

Preferred

• 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. 
   

JOB DUTIES

• 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, Skills and 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.

PHYSICAL REQUIREMENTS/WORKING CONDITIONS

Working Conditions

• Clinical Setting
• Office Setting

Salary Information
Salary is commensurate with education, skills, and relevant experience.

SECURITY AND EEO STATEMENT

Security
This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.

EEO
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.