Manager, Clinical Research, General Internal Medicine

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
Are you passionate about using research to solve pressing issues in health care delivery, outcomes, and equity? UTSW is seeking an individual with these interests - along with exceptional management, leadership, critical thinking, and organizational skills - to join the Division of General Internal Medicine as a Clinical Research Manager. The selected candidate in this position will join a dynamic growing research unit and support the principal investigator and junior researchers to oversee on-going research studies, develop short- and long-term goals and objectives, make operational and programmatic decisions for successful studies, maintain collaborative relationships with stakeholders, partnering institutions and differing UTSW departments, direct financial oversight, recruit staff and participate in training. Additionally, supervise staff, identify sponsors for clinical research, and develop marketing strategies.

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 science, social science, business, health-related (including nursing) field or
  Master's Degree in science, social science, business, or health-related (including nursing) field or
  PhD or equivalent in science, social science, business, or health-related (including nursing) field

• Experience
  6 years of related experience to include management experience with Bachelor's Degree or
  4 years of related experience to include management experience with Master's Degree or
  3 years of related experience to include management experience with PhD.
  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 Qualifications

• Experience
• 5+ years in clinical research management, leading cross-functional teams.
• Hands-on experience with IRB/FDA submissions, regulatory compliance, and trial oversight.
• Proven track record in managing clinical trial budgets and vendor relationships.
• Technical Skills
• Proficiency in observational analysis, clinical trial management systems (EDC, TMF) and project management tools.
• Knowledge of Six Sigma and quality assurance frameworks is a plus.
• Leadership & Communication
• Strong team management skills with the ability to mentor and oversee staff.
• Clear communication with PIs, sponsors, and regulatory bodies.
• Education
• Master's degree in Health Policy, Public Health, Health Services Research, or related field.

• Licenses and Certifications
  Heart Saver may be required based on research study protocols or affiliate location requirements. Upon Hire or
  (BLS) BASIC LIFE SUPPORT BLS for Licensure may be required based on research study protocols or affiliate location requirements. Upon Hire

JOB DUTIES

• Reviews proposed new research studies and determines projects to implement; negotiates budget and contract issues; initiates regulatory activities; oversees preparation of necessary project summaries, consent forms, etc. for IRB; oversees compliance with all regulatory requirements.
• Oversees on-going research studies and quality assurance measures, developing criteria where necessary; negotiates favorable agreements with laboratories and collaborators on campus; monitors profitability of research studies; renegotiates contracts, supplements, etc. as needed.
• Directs financial oversight and management of clinical research unit; ensures invoicing is accurate and sponsor payments are received; ensures appropriateness of expenditures from various funding sources available to clinical research unit.
• Participates in selection process of clinical research unit staff; provides training to research, financial, laboratory, and administrative staff; evaluates staff performance and implements measures necessary to maintain quality performance and results; participates in training, development, and/or disciplinary measures; assesses policies and procedures to ensure optimal operation of clinical research unit.
• Identifies potential sponsors for clinical research unit; develops and oversees marketing strategies.
• Initiates and maintains collaborative relationships between clinical research unit and basic science facilities.
• Designs, executes, and maintains effective system of internal controls which provides reasonable assurance that operations are effective and efficient, assets are safeguarded, and financial information is reliable.
• Ensures compliance with applicable laws, regulations, policies, and procedures.
• 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.

Master's degree in Health Policy, Public Health, Health Services Research, or related field.

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 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.

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!