Clinical Research Assistant II, Endocrinology

University of Texas Southwestern Medical Center; Dallas (TX); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

PPO medical plan

Paid Time Off

Tuition Reimbursement

Public Service Loan Forgiveness (PSLF)

Job summary

UT Southwestern Medical Center in Dallas, TX, seeks an experienced data manager to provide ongoing data management for local and national research studies under supervision. You will identify eligible subjects from charts, prepare data for IRB, and support non-treatment/treatment trials as needed.

This role emphasizes data integrity, entering data into CRFs, addressing data queries, and assisting with audits and regulatory submissions.

Qualifications

• Education requirements include a high school diploma or higher in a medical/science field.
• PreferredBachelor's degree in a medical or science field.
• Experience: 2 years with HS diploma or 1 year with Associate's degree.

Responsibilities

• Understands visit schedules, criteria and protocol requirements for low complexity trials; schedules research visits.
• Assists research staff by completing protocol related tasks.
• Reviews and abstracts information from medical records including eligibility criteria.
• Enters data into case report forms or other data collection system; maintains study documentation.
• Assists with data queries and edits for accuracy.
• Compiles data for regulatory requirements or sponsor deadlines.
• Maintains databases and ensures data integrity.
• Performs QA/QC clinical analysis and data checks.
• Prepares annual reports and IRB modifications; may include UPIRSO.
• Assists with research records for sponsor or internal audits.
• Recruits and enrolls patients; may consent with supervision.
• Assists with participant screening for more complex trials.
• Conducts and documents consent; develops consent plans.
• Identifies incomplete or missing data; works to correct errors.
• Orders and maintains research supplies; ensures equipment works.
• Assists with collecting and processing specimens.
• Prepares studies for closeout; packs files for storage.
• Performs study procedures as needed; rests on credentialing.
• May perform patient care under PI supervision.
• Duties include direct patient interaction and handling patient records.

Education

High School Diploma or Associate's Degree in medical or science related field or Bachelor’s Degree medical or science related field

Bachelor's Degree in medical or science related field

Job description

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 number 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 position will be responsible for preparing statistical information for each subject entered in or removed from our research studies. They identify subjects for the studies by means of reviewing charts to see if criteria is met. This position also prepares data for IRB and submits confidential records and research materials.

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

• Education

  Bachelor's Degree in medical or science related field

• Experience

  Patient-facing experience such as Medical Assistant, Phlebotomist, Scribe or similar.

• 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.

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.