Clinical Research Assistant I, Pediatrics

UT Southwestern Medical Center • Dallas, TX

5d

About The Position

Works under the direction of an Investigator(s) with general supervision, to primarily provide ongoing data management for local and national research studies. May coordinate observational (non-treatment) studies.

This position will be responsible for maintaining daily expectations of a Clinical Research Assistant and aiding and maintaining requirements for PI's laboratory and study activities and newly awarded projects.

Requirements

• High School Diploma or GED

Nice To Haves

• (BLS) BASIC LIFE SUPPORT may be required based on research study protocols or affiliate location requirements.
• (CPRAED) CPR AED may be required based on affiliate location requirements

Responsibilities

• 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, 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.

Benefits

• PPO medical plan, available day one at no cost for full-time employee-only coverage
• 100%25 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees