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 coordinate research projects. This position primarily performs patient/participant coordination, however, may conduct data management in smaller departments on as needed basis. Provides supervision to a team engaged in the execution of multiple, complex research protocols.

This position will supervise the Regulatory Assistants/Regulatory Associates (RAs) for oncology and hematology clinical trials. 

ESSENTIAL FUNCTIONS include:

1.    Oversees the day-to-day activities of the RA team.  Develop performance standards and expectations for the RA team and periodically assesses the attainment of those standards.
2.    Manages work schedules and conducts performance reviews for RAs.
3.    Oversees training for new and existing employees.
a.    Ensure all training is clearly documented for employee’s file.
b.    Train new team members during their onboarding.
c.    Supervision of training for existing team members.
4.    Organization of regular RA team meetings and oversees creation of agendas as well as meeting minutes.
5.    Assists Regulatory Operations Manager with activation of studies which includes:
a.    Monitoring activation to identify any additional resources needed or workflows which might need modification. 
i.    Assists in working through any obstacles identified during the submission process
6.    Maintains working relationships with faculty and academic departments across UTSW to help oversee the conduct of hematology and oncology clinical trials.
7.    Acts as a working manager role of a RA. Will continue to have studies assigned (while not a full load) while managing the team.
8.    Work with DOT Managers to prioritize study submissions and manage regulatory monitoring visits and audits.
9.    Manages the progress of new trials through regulatory submission and approval.
10.    Recommends and/or creates new policies and procedures for improvement of program compliance activities.
11.    Quality checks of regulatory binders/essential regulatory documents across the regulatory team.
12.    Complete and maintain RCR registration process for investigators
13.    Performs other duties as assigned.

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
  5 years of clinical research experience. and
  May consider additional years of experience or advanced degree in lieu of education or experience, respectively.
  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.

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

Preferred

• Licenses and Certifications
  ACRP or SOCRA certification a plus. Upon Hire and

JOB DUTIES

• Assists with the daily operations for the research unit, to include but not limited to staffing, protocol management, budgeting, and regulatory requirements.
• May assist in development of study design, implementation, and administration for new studies ensuring compliance with HRPP/IRB requirements, Federal/State regulations, and grant and/or contract parameters.
• Assists with monitoring and oversight of active clinical research protocols in accordance with internal policies, federal and state regulations, and University policies.
• Oversees and coordinates data collection and assures accuracy and timely submission to sponsors and/or external
• Oversees and coordinates the scheduling and efficient usage of research facilities.
• Performs research billing activities (including linking patient calendars) and oversees the financial status of the research protocols for the team
• Monitors patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards
• 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.

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.