Clinical Research Assistant Lead, Internal Medicine

UT Southwestern Medical Center • Dallas, TX

1d • Onsite

About The Position

Works under the direction of an Investigator(s) with limited supervision, to provide ongoing data management for local and national research studies and may coordinate observational (non-treatment/treatment) trials/studies. Works on complex studies in a lead role, under the direction of the PI and/or Clinical Research Coordinator. The Clinical Research Assistant Lead will serve as an experienced research professional with lead responsibilities, independently coordinating study protocols, participant visits, laboratory procedures, data management, and day-to-day research operations while performing all Clinical Research Assistant II duties. The role includes serving as the lead research assistant for assigned studies, overseeing data entry and quality review, resolving data queries, monitoring protocol compliance, providing operational support, and training and mentoring CRA I/II staff.

Requirements

• High School Diploma or Associate's Degree in medical or science related field or Bachelor's Degree or higher in medical or science related field
• 4 years of experience with High School Diploma or 2 years of experience with Associate's Degree or 1 year of experience with Bachelor's Degree or higher

Nice To Haves

• Prior experience in the UTSW clinical research mentoring program is highly desirable, and participation in the UTSW clinical research mentoring program may count as additional experience.
• (BLS) BASIC LIFE SUPPORT may be required based on research study protocol or affiliate location requirements.
• (CPRAED) CPR AED may be required based on research study protocol or affiliate location requirements.

Responsibilities

• Assists with participant screening and recruitment for complex trials or multiple research studies at any given time.
• Conducts and documents consent for participants in studies. Develops consent plans and documents for participants.
• Independently corrects and documents incomplete, inaccurate, or missing data for more complex studies.
• Understands visit schedules, criteria and protocol requirements for complex trials; schedules research visits, etc.
• Completes research protocol related tasks.
• Reviews and abstracts information from medical records including eligibility criteria.
• Recruits and enrolls patients in research study that may include consenting patients.
• 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.
• Assists with ordering and maintaining research supplies following university/department procedures, ensuring that equipment is in good working order.
• Assists with collecting and processing specimens following established procedures/protocols.
• 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.
• May provide working supervision or direction of lower level Clinical Research Assistants.
• 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.
• 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: Mid Level
• Education Level: High school or GED