Clinical Research Assistant I, Internal Medicine Digestive and Liver

UT Southwestern Medical Center • Dallas, TX

1d • Onsite

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. The Clinical Research Assistant I may assist with research studies by entering and maintaining study data, ensuring data integrity, supporting regulatory and IRB submissions, coordinating study visits, screening and enrolling participants, maintaining study documentation, collecting and processing specimens, performing study-related procedures (with appropriate training), managing research supplies, preparing studies for closeout, and supporting research staff with protocol-related activities while ensuring compliance with study and institutional requirements. Performs other duties as assigned.

Requirements

• High School Diploma or GED

Nice To Haves

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