Clinical Research Assistant Lead, Internal Medicine

The University of Texas Southwestern Medical Center; Dallas (TX); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

PPO medical plan

Paid Time Off

TRS

Paid Parental Leave

Tuition Reimbursement

Job summary

The University of Texas Southwestern Medical Center is seeking a Clinical Research Assistant Lead in Internal Medicine to oversee data management, study coordination, and lead research staff on complex trials.

This role involves independently coordinating protocols, participant visits, lab procedures, data entry, quality review, and regulatory tasks under the PI and CRA leadership. Prior mentoring experience is valued in a collaborative, mission-driven environment.

Qualifications

• 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

Responsibilities

• Screen and recruit participants for complex trials.
• Obtain consent and coordinate visits.
• Enter and maintain data in study records and case report forms.
• QA/QC data checks and regulatory reporting.
• Mentor CRA I/II staff as needed.

Skills

Data management

Mentoring

Education

High School Diploma

Associate's Degree

Bachelor's Degree or higher in medical or science related field

Job description

Job Description - Clinical Research Assistant Lead, Internal Medicine (964730)

Job Description

Clinical Research Assistant Lead, Internal Medicine - ( 964730 )

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 number 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 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.

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 or higher in medical or science related field
• Experience
  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
  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.

Preferred

• Licenses and Certifications
  (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.

JOB DUTIES

• 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.

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]