Supervisor Clinical Research

University of Texas Southwestern Medical Center; Dallas (TX); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Healthcare benefits

PTO and paid holidays

On-site childcare

Merit increases

Job summary

UT Southwestern Medical Center is seeking a Clinical Research Coordinator to coordinate multiple research projects under limited supervision in Dallas, TX. The role focuses on patient/participant coordination and may involve data management for smaller departments.

You will write SOPs, create training materials, conduct internal audits, assist with study protocols, and manage IRB communications while supervising two junior staff along with regulatory oversight.

Qualifications

• Bachelor's Degree in medical or science related field.
• 5 years of clinical research experience. May consider additional years or advanced degree in lieu of education or experience.
• Prior experience in mentoring or mentoring programs highly desirable.

Responsibilities

• Write and update standard operating procedures for the clinical research team.
• Create training material for new clinical research staff.
• Perform internal regulatory audits of all currently open clinical trials.
• Assist in development and writing of new study protocols.
• Oversee submissions and communications with external central IRBs.
• Coordinate regulatory compliance with CROs and sponsors and lead audit responses.
• Supervise two lower level clinical research staff.

Skills

Clinical research terminology

Computer skills (spreadsheets, Databs)

Effective communication

PHI regulations

Problem solving

Confidential data handling

Education

Bachelor's Degree in medical or science related field

Tools

Interactive web-based software

Job 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 No. 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 youll 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.

• Write and update standard operating procedures for the clinical research team.

• Create training material for new clinical research staff.

• Perform internal regulatory audits of all currently open clinical trials.

• Assist in development and writing of new study protocols.

• Oversee all submission and communications with external central IRBs.

• Coordinate regulatory compliance with CROs and sponsors. Lead response to internal and external regulatory audits.

• Supervise two lower level clinical research 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
• 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. 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.

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 or SOCRA certification a plus.

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.

Knowledge, Skills and Abilities

• Work requires knowledge of basic and clinical research terminology, regulations, and procedures.
• Work requires strong computer skills (spreadsheets, databases, and interactive web-based software).
• Work requires ability to communicate effectively with various levels of internal and external contacts.
• Work requires ability to work with confidential information on daily basis
• Proactively works to maximize results of the team and organization
• Follows and understands the regulations for Protected Health Information (PHI)
• Work requires good communication skills.
• Work requires the ability to problem solve.

PHYSICAL REQUIREMENTS/WORKING CONDITIONS

Working Conditions

• Office Setting

Salary Information

Salary is commensurate with education, skills, and relevant experience.

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.