Clinical Research Coordinator Lead, SCCC

Clinical Research Coordinator Lead, Simmons Cancer Center

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Job Summary

The Simmons Cancer Center is hiring a Clinical Research Coordinator Lead. This is a non-clinical role (no patient contact) and a bridge position for the FU/POP/Phase 1 disease-oriented teams (DOT) for regulatory and time to activation support. Candidate will be responsible for the following duties:

• Perform regulatory duties across GU/MPOP/Phase 1 disease-oriented teams Prepare and manage IRB Submissions (including responding to stipulations by ancillary review committees); new studies, modifications, etc.
• Enter modifications in the database for tracking and billing
• Prepare essential regulatory documents for signature and ensures submission to study sponsor for GU/MPOP/Phase 1 disease-oriented teams
• Regulatory binder management
• Time to Activation (PC) duties: Study activation duties; Budget drafting and negotiations; Study process flow
• Other duties as assigned for GU/MPOP/Phase 1 disease-oriented teams (DOT) regulatory administration (RA/PC duties)

Experience and Education

• Bachelor's degree in medical or science related field and four years of clinical research experience.
• May consider additional years of experience or advanced degree in lieu of education or experience, respectively.
• ACRP or SOCRA certification a plus.
• A Heart Saver for non-licensure or BLS for Licensure may be required based on research study protocols or affiliate location requirements.
• 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.

Job Duties

• Maintains required subject documentation for each study protocol.
• Directly interacts with clinical research participants, as required, for the research study (non-clinical and clinical procedures). Interacts via telephone, telehealth or in-person.
• Coordinates regulatory documentation for research studies that includes maintaining information to comply with industry standards, University policies, FDA requirements or other hospital policies.
• Coordinates and schedules procedures as per research study. A non-licensed coordinator may pend study order sets with oversight by PI.
• Screens, recruits, enrolls and follows subjects according to research protocol guidelines (non-clinical and clinical procedures). May also assist with the consent processes.
• 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 provide supervision to other members of the research team as necessary.
• May perform research billing activities, as needed, based on size of department (including linking patient calendars
• Monitors patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards.
• Assists PI/supervisor with daily activities of the research team and functions as a liaison between clinical research investigators and various organizations/departments and agencies including, but not limited to HRPP, FDA, Sponsored Programs, and affiliated hospitals.
• Coordinates data management and collection for national (larger/more complex) research studies.
• Serves as 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.
• Assists and monitors and/or maintain research study budgets. Assists the PI with the fiscal management of the trial. Ensures that the patient care charges are allocated appropriately for various research studies.
• 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 in the assigned clinical trial management system, electronic medical record and/or other required data entry systems.
• 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 & Abilities

• Knowledge of applicable Federal and institutional regulations governing clinical research.
• Knowledge of clinical research protocols.
• Effective organizational skills and attention to detail.
• Proactively works to maximize results of the team and organization.
• Follows and understands the regulations for Protected Health Information (PHI).
• Proactively works to maximize results of the team and organization.
• Possess strong computer skills (spreadsheets, databases, and interactive web-based software).
• Possess good communication skills.
• Possess the ability to problem solve.
• Work requires ability to conduct interviews with research subjects.

To learn more about the benefits UT Southwestern offers, visit https://www.utsouthwestern.edu/employees/hr-resources/

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.