Bachelor's Degree in a medical or science-related field
5 years of clinical research experience
Experience in the UTSW clinical research mentoring program is highly desirable
Basic Life Support (BLS) certification may be required
ACRP or SOCRA certification is a plus
Responsibilities
Coordinate research projects under limited supervision
Write and update standard operating procedures for the clinical research team
Create training materials for new clinical research staff
Perform internal regulatory audits of open clinical trials
Oversee submission and communications with external central IRBs
Supervise two lower-level clinical research staff
Assist in the development and writing of new study protocols
Benefits
PPO medical plan available day one at no cost for full-time employee-only coverage
100% coverage for preventive healthcare with 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
Full Job Description
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.
About University Of Texas Southwestern Medical Center
The University of Texas Southwestern Medical Center (UT Southwestern) is a public academic health science center in Dallas, Texas. With approximately 14,400 employees and an operating budget of nearly $2.8 billion, UT Southwestern is one of six medical schools in the UT System. UT Southwestern is one of the leading medical research institutions in the world, with a focus on biomedical research, clinical care, and education. The institution is home to six Nobel laureates, 22 members of the National Academy of Sciences, and 19 members of the National Academy of Medicine. UT Southwestern is also affiliated with Parkland Memorial Hospital, one of the largest public hospitals in the United States.
