Clinical Research Coordinator II

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. Collects and ensures quality control of clinical or basic research data in support of multiple and/or complex research studies.

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
• Retail Programs through the Teacher Retirement System of Texas (TRS)
• Paid Parental Leave
• Wellness programs
• Tuition Reimbursement
• Public Service Loan Forgiveness (PSLF)

Required EXPERIENCE AND EDUCATION

• Education: Bachelor's Degree in medical or science related field
• Experience: 2 years years clinical research experience. May consider additional years of experience or advanced degree in lieu of education or experience, respectively.

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.
• AACR or SOCRA certification a plus.

Job Duties

• Directly interacts with clinical research participants, as required, for the research study (non-clinical and clinical procedures).
• Interacts via telephone, telehealth or in-person.
• Captures and ensures quality control of clinical or basic research data in support of multiple and/or complex research studies.
• Coordinates regulatory documentation for research studies that includes maintaining information to comply with industry standards, University policies, FDA requirements or other hospital policies.
• Screens, recruits, enrolls and follows subjects according to research protocol guidelines (non-clinical and clinical procedures).
• Maintains and coordinates data collection information required for each study that may also include developing CRF's (case report form) or data collection tools.
• Assists in developing and implementing research studies, may include writing clinical research protocols.
• Conducts research procedures according to the protocol with proper training and check offs to maintain scope of service.
• May assist the PI on the fiscal management of the trial including budget preparation.
• Makes sure patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards.
• May perform research billing activities, as needed, based on size of department (including linking patient calendars).
• Coordinates data management and collection for national (larger/more complex) research studies or multiple research studies at a given time.
• Serves as primary liaison/lead in preparing annual reports for federal, state, and or/or local agencies on assigned studies.
• Prepares protocols for Institutional Review Board (IRB) submission. May also submit amendments and continuing review documents.
• Provides in-service training to all study team members and communicates to involved groups.
• Reviews research study protocols to ensure feasibility requirements of the study.
• Assists in developing website or other social media for marketing/recruiting based on assigned clinical research study.
• Enters data or assists in assembling data to enter in the assigned clinical trial management system, electronic medical record and/or other required data entry systems.
• Maintains required subject documentation for each study protocol.

SECURITY AND EEO STATEMENT

• This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.
• 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.