Lead Clinical Research Coordinator – Cardiovascular & Thoracic Surgery Department

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
The Department of Cardiovascular and Thoracic Surgery at UT Southwestern is seeking a full-time Clinical Research Coordinator Lead to play a key role in regulatory support.

The Regulatory Clinical Lead will have a pivotal role in overseeing the regulatory compliance of clinical trials and grant submissions. This role will require the individual to manage all clinical trial activities, ensure adherence to regulations, prepare necessary budgets and grants, and collaborate with multi-disciplinary teams. Managing sponsor and internal audits will also be essential responsibilities. The role is critical for ensuring the success and safety of clinical trials. Experience in Cardiovascular and Thoracic Surgery, Oncology, or Clinical Research is strongly preferred.

This is a unique opportunity to play a leading role in the development and execution of innovative clinical research in the Department of Cardiovascular and Thoracic Surgery. You’ll work alongside world-class surgeons, researchers, and healthcare professionals, contributing to advancements that impact patient care and surgical outcomes.

The ideal candidate will have the following qualifications:

• Familiarity with regulatory submission processes and the associated documentation.
• Proficiency in regulatory compliance frameworks such as FDA, ICH-GCP, and HIPAA.
• Experience in budget preparation and grant management.
• Strong leadership and communication skills.
• Excellent organizational and time-management abilities.
• Attention to detail and commitment to patient safety.
• Proactive problem-solving mindset.
• Ability to collaborate effectively with multidisciplinary teams.
• In-depth knowledge of clinical trial management, from initiation to close-out.

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
• 100% 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
• Learn more about these and other UTSW employee benefits!

EXPERIENCE AND EDUCATION
Required

• Education
  Bachelor’s Degree in medical or science related field

• Experience
  4 years of clinical research experience with Bachelor’s Degree
  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.
  May consider additional years of experience or advanced degree in lieu of education or experience, respectively.

Preferred

• Licenses and Certifications
  (BLS) BASIC LIFE SUPPORT may be required based on research study protocols or affiliate location requirements.
  (CPRAED) CPR AED may be required based on research study protocols or affiliate location requirements.
  ACRP of SOCRA certification a plus.

JOB DUTIES

• Lead the regulatory strategy for clinical trials and regulatory submissions in accordance with regulatory requirements (FDA, EMA, etc.).
• Ensure all trial activities are compliant with Good Clinical Practice (GCP), ethics, and regulatory guidelines.
• Collaborate with interdisciplinary teams, including Cardiac and Thoracic Surgeons, Medical Oncologists, research coordinators, and research nursing teams, to initiate, monitor, and maintain clinical trials.
• Manage clinical trial budgets, grants, and funding proposals.
• Provide guidance on risk management strategies to safeguard patient safety during trials.
• Communicate with regulatory bodies and stakeholders to ensure timely and accurate submission of required documentation.
• Track and report progress of ongoing trials, addressing any challenges or issues proactively.

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. To the extent this position requires the holder to research, work on, or have access to critical infrastructure as defined in Section 113.001(2) of the Texas Business and Commerce Code, the ability to maintain the security or integrity of the critical infrastructure is a minimum qualification to be hired and to continue to be employed in the position.

EEO Statement
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.