Clinical Research Assistant II

The University of Texas Southwestern Medical Center; Dallas (TX); On-site; USD 60,000 - 95,000; Full time

Benefits offered by this job

PPO medical plan

Paid Time Off

Retirement Programs (TRS)

Paid Parental Leave

Wellness programs

Tuition Reimbursement

Public Service Loan Forgiveness (PSLF)

Job summary

UT Southwestern Medical Center in Dallas seeks a Clinical Research Data Coordinator to manage data for local and national studies, collect blood samples, and maintain regulatory records. You will enter data into databases, assist with IRB submissions, and support sponsor inquiries.

A phlebotomy certification is required within 6 months, and candidates may need to travel for offsite visits using their own car.

Qualifications

• Phlebotomy certification within 6 months of hire.
• Own car for offsite patient visits when needed.
• Bachelor's or Associate's degree in medical/science field is preferred or required.

Responsibilities

• Collect, process, and ship research blood samples.
• Enter data into case report forms and databases; maintain documentation.
• Maintain consent files and IRB records; support IRB submissions.
• Assist PI with regulatory submissions and sponsor inquiries; audits.
• Recruit and enroll patients; screen and enroll with supervision.
• Perform phlebotomy and related measurements as needed for studies.
• Support study closeout, data quality checks, and regulatory reporting.

Skills

Data management

IRB documentation

Clinical research procedures

Communication skills

Phlebotomy

Education

Bachelor's degree in medical or science related field

Associate's degree in medical or science related field

High School Diploma

Tools

EDC / Electronic data capture

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 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.

Collect, process, and ship research clinical trial patient blood samples. Draws blood from adult and pediatric study patients.

Maintain study subject consent files, IRBs, and enters data on subjects into database.

Assist PI with IRB record keeping and obtaining informed consent from subject families; responds to study inquires/audit info requests from trial sponsor on behalf of principal investigator.

Phlebotomy certification required within 6 mos. of hire.

Candidate must have own car to collect blood from offsite patients when needed. Mileage reimbursement provided

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
• 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
• 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.

UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. In accordance with federal and state law, the University prohibits unlawful discrimination, including harassment, on the basis of: race; color; religion; national origin; gender, including sexual harassment; age; disability; citizenship; and veteran status. In addition, it is UT Southwestern policy to prohibit discrimination on the basis of sexual orientation, gender identity, or gender expression.

Copyright 2017.The University of Texas Southwestern Medical Center5323 Harry Hines Blvd., Dallas, Texas 75390Phone [phone]