Clinical Trials Research Associate - Cancer Center

The Holden Comprehensive Cancer Center at the University of Iowa is seeking a Clinical Trials Research Associate to serve as a member of the Clinical Trials Research team to coordinate clinical oncology study activities: assist in the planning, delivery and evaluation of health care provided to research protocol patients; work closely with Clinical Research Coordinators in the collection of data and in close collaboration with multiple departments and offices, including the University Clinical Trials Office; maintain medical documentation, binders and files; manage data entry and electronic data systems for clinical research protocols and laboratory investigations currently being conducted within the Holden Comprehensive Cancer Center (HCCC) at The University of Iowa.

Duties to include:

60% list core duties

•          Functions as a member of the Clinical Research Services team to plan, deliver, and evaluate the health care provided to research protocol patients.
•          Assists in the design, development, execution and administration for protocols and clinical studies.
•          Oversees operations of clinical research studies including the recruitment, screening, coordination and scheduling of subject participation and procedures as required by protocol.
•          Obtains informed consent; educates study participants on the scope of study, schedule of events per clinical trial protocol and requirements of participation.
•          Follows study participants; manages collection of data including maintaining records of patient visits/interviews, documentation of adverse events, and review of medication records.  Provides documentation for physician review to ensure patients are screened and treated according to protocol.
•          Documents medical histories, symptoms, vital signs, treatments and results for assigned patients according to research protocol; reviews results to ensure quality and accuracy of data gathered; communicates with physician to assist in eligibility determination.
•          Monitors compliance, gathers and maintains data for pharmaceutical sponsored research trials, in-house trials and cooperative group studies; develops complex study materials; creates worksheets, treatment flow sheets and assorted tools to ensure accurate source documentation of protocol treatment procedures; triages telephone calls from patients and families to facilitate clinic visits for medical care/emergency care needs; assists in obtaining prescription medications; ensures follow up care is conducted in alignment with clinical trial protocol.
•          Collaborates with departments of Radiology, Pathology, Pharmacy, Nursing, Holden Comprehensive Cancer Center, Clinical Research Unit and/or other departments participating in the clinical research to ensure multi-disciplinary patient safety approaches; conveys study specific objectives and requirements; develops communication tools as necessary.
•          Enters patients on protocol, ensuring that all prerequisites have been completed and are within the required parameters.
•          Serves as liaison to local physicians/hospitals to facilitate care of protocol patients when hospitalized at outside institutions; obtains documentation of the hospitalizations; provides notification to the Principal Investigator, Study Sponsor, and FDA as required per protocol.
•          Performs critical analysis of literature relevant to the clinical trials.
•          Educates faculty, staff and others about clinical research