Clinical Research Assistant II, Pediatric Neurology

UT Southwestern Medical Center • Dallas, TX

1d • Onsite

About The Position

Works under the direction of investigator(s) with general supervision to provide ongoing data management for local and national research studies and may coordinate observational or treatment trials and studies. The role may support more complex studies under the direction of the principal investigator, Clinical Research Coordinator, and/or Clinical Research Lead.

This position is in the Department of Pediatrics, supporting the division of Neurology, and primarily supports investigator-initiated studies, including natural history studies and a biorepository. Duties include patient recruitment, consenting, data collection and entry, biospecimen collection and processing, query resolution, and regulatory management. The role is part of a collaborative team environment. Experience with REDCap is strongly preferred but not required.

Requirements

• High school diploma and 2 years of experience, or an associate degree in a medical or science-related field and 1 year of experience, or a bachelor's degree in a medical or science-related field with no prior experience.
• Knowledge of applicable federal and institutional regulations governing clinical research.
• Knowledge of clinical research protocols.
• Effective organizational skills and attention to detail.
• Ability to work proactively to maximize team and organizational results.
• Understanding of regulations for protected health information (PHI).
• Strong computer skills, including spreadsheets, databases, and interactive web-based software.
• Good communication skills.
• Problem-solving ability.
• Ability to conduct interviews with research subjects.

Nice To Haves

• Experience with REDCap is strongly preferred but not required.
• Basic Life Support (BLS) certification may be required based on affiliate location requirements.
• CPR AED certification may be required based on affiliate location requirements.

Responsibilities

• Understand visit schedules, criteria, and protocol requirements for low-complexity trials and schedule research visits.
• Assist research staff with research protocol-related tasks.
• Review and abstract medical-record information, including eligibility criteria.
• Enter data into case report forms or other study data collection systems and help maintain study-level documentation.
• Assist with data queries and edits for accuracy.
• Compile data for regulatory requirements and local or sponsor submissions.
• Maintain existing databases and ensure data integrity.
• Perform QA/QC clinical analysis and data checks using databases relevant to the trial.
• Assist with annual reports and modifications to the institutional review board, including reportable events.
• Prepare research records for sponsor or internal audits.
• Recruit and enroll patients; conduct consent after training and with supervision.
• Assist with screening and recruitment for more complex trials after adequate training and supervision.
• Conduct and document participant consent, and assist with developing consent plans and documents.
• Identify incomplete, inaccurate, or missing data for more complex studies and work with the lead coordinator to correct errors.
• Assist with ordering and maintaining research supplies and ensure equipment is in good working order.
• Collect and process specimens according to established procedures and protocols after adequate training and supervision.
• Assist in preparing studies for closeout, including packing and documenting files for storage and returning extra supplies to sponsors.
• Perform study procedures such as phlebotomy, vital signs, and EKGs when adequately trained, credentialed, and supervised; other procedures or equipment may be required depending on the study.
• May perform basic patient care under the direction of the PI and in accordance with the scope of work document.
• Perform other duties as assigned.

Benefits

• PPO medical plan, with employee-only full-time coverage available at no cost starting day one.
• Preventive healthcare coverage at 100% with no copay.
• Paid time off available day one.
• Retirement programs through the Teacher Retirement System of Texas (TRS).
• Paid parental leave.
• Wellness programs.
• Tuition reimbursement.
• Public Service Loan Forgiveness (PSLF) qualified employer.
• Competitive and comprehensive benefits package, including healthcare and paid holidays.
• On-site childcare.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED