Supervisor Clinical Research

UT Southwestern Medical Center • Dallas, TX

11d • Onsite

About The Position

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.

Requirements

• Bachelor's Degree in medical or science related field.
• 5 years of clinical research experience.
• 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.
• Follows and understands the regulations for Protected Health Information (PHI).
• Work requires good communication skills.
• Work requires the ability to problem solve.

Nice To Haves

• 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.
• (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.

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 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.
• 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.

Benefits

• PPO medical plan, available day one at no cost for full-time employee-only coverage
• 100%25 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level