Clinical Studies Coordinator Genitourinary Medical Oncology

At UT MDA the Clinical Studies Coordinator [Patient Care] will be responsible for clinical trials that pose 'Minimal Risk' or 'Greater than Minimal Risk' to research subjects. Minimal Risk to subjects means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical and psychological examinations or tests and that confidentiality is adequately protected (as defined in eCFR §46.102).

Greater than Minimal Risk to subjects means that the probability and magnitude of harm or discomfort anticipated in the research risks are more than minimal risk, but not significantly greater.

In addition, the Clinical Studies Coordinator [Patient Care] may assist a Research Nurse for the execution and communication of clinical trials that pose 'Significantly Greater than Minimal Risk' to research subjects. 'Significantly Greater than Minimal Risk' to subjects means that there is a probability of an event that is serious, prolonged and/or permanent occurring as a result of study participation or there is significant uncertainty about the nature or likelihood of adverse events.

• Employer-paid medical coverage starting day one for employees working 30+ hours/week, plus optional group dental, vision, life, AD&D, and disability insurance.
• Accruals for PTO and Extended Illness Bank, plus paid holidays, wellness, childcare, and other leave options.
• Tuition Assistance Program after six months of service and access to extensive wellness, fitness, and employee resource groups.
• Defined-benefit pension through the Teachers Retirement System, voluntary retirement plans, and employer-paid life and reduced salary protection programs.

• In collaboration with the Principal Investigator, Protocol Team, sponsor(s) and supporter(s) assumes responsibility for the effective and safe operation of research protocols.
• Demonstrates intimate knowledge of protocol content and mandated procedures, consistently following the most recent IRB approved version of the protocol.
• Maintains up to date knowledge of departmental and institutional databases and tools for execution of clinical trial workflow such as ePRTCL, CORe, Prometheus, Clinical Trials.gov, Microsoft Office and others as indicated.
• Collaborates with the Protocol Team in the pre-activation set up of the protocol in departmental and institutional databases and in the proper execution of the clinical trial.
• Prepares for, attends and participates in all Study Initiation visit(s).
• Communicates frequently and effectively with Protocol Team in order to maintain up to date knowledge of all assigned protocol(s) participants' status.
• Participates in the informed consent process to enable and ensure its proper execution.
• Conducts successful patient recruitment, scheduling and retention through the accurate assessment of patients for protocol eligibility (through personal interviews as well as retrieval and detailed review of medical records from internal and external healthcare facilities as needed) in the outpatient and inpatient settings.
• Monitors and coordinates the care of protocol participants in the inpatient and outpatient clinical settings ensuring protocol mandated evaluations and treatments are accurately fulfilled.
• Generates required documentation and disposes of left-over investigational drugs as per departmental and institutional mandates.
• Identifies adverse events experienced by study participants and facilitates their management and follow-up under the guidance of the treating provider and Principal Investigator, until resolution or other, as per protocol mandate.
• Identifies and addresses patient and caregivers' education needs regarding treatments and evaluations on protocol via in-person, telephone, video conferencing tools and/or appropriate written education material, as needed.
• Must be able to independently manage assignments without supervision.

• Demonstrates excellent verbal and written communication skills.
• Effectively communicates the participants' experience on the study to the PI, the IRB, the protocol sponsor(s) and supporter(s) and regulatory agencies by generating timely documentation of relevant information and results of study mandated evaluations in the patient's medical record (and other platforms as needed) as per protocol, departmental and institutional requirements.
• Provides detailed and timely…