Pediatric Oncology - Clinical Trials Research Associate

Within the Stead Family Department of Pediatrics, Division of Oncology, the Clinical Trials Research Associate serves as a member of the Pediatric Oncology Research Team to coordinate Pediatric clinical 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) and Stead Family Children’s Hospital at The University of Iowa. This is a specified term position.

Position Responsibilities

• Functions as a member of the Pediatric Oncology Research Team to plan, deliver, and evaluate the health care provided to research protocol patients.
• Creates, populates, maintains, and enhances multiple databases containing clinical and research information obtained through review of patient charts and samples, lab reports and other related source documentation and in a manner that complies with Institutional Review Board requirements and in response to physician and research needs and requirements.
• Assists in the design, development, execution and administration of data entry for protocols and clinical studies.
• Assists in the operations of clinical research studies including the recruitment, coordination and scheduling of subject participation and procedures as required by protocol.
• Follows study participants; manages collection of data including maintaining records of patient visits and assessments.
• Enters protocol patient data on electronic databases ensuring that all prerequisites have been completed and are within the required parameters.
• Monitors compliance, gathers and maintains data for pharmaceutical sponsored research trials, in-house trials and cooperative group studies; creates worksheets, treatment flow sheets and assorted tools to provide source documentation of protocol treatment procedures; assists in obtaining prescription medications; provides follow-up for treatment related complications.
• 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.
• Assists in judging validity of data; makes recommendations; performs and interprets statistical analysis of data; prepares data for computer analysis; uses evaluation data to revise and implement change in close collaboration with the clinical research coordinator.
• Assists in the preparation of periodic and special reports, including reports to IRB-01, Protocol Review and Monitoring Committee and other review committees for multiple clinical research studies; compiles accrual data; reviews and summarizes information for principal investigators and University Institutional Review Board (IRB-01).
• Maintain and secure documentation of protocols and relevant data, follow-up correspondence, and summaries.
• Assists in the preparation of materials for reports to be written by faculty and staff on various oncology protocols and in compiling summary data for inclusion in various reports used for analysis and submission to study sponsors.
• Coordinates ongoing research collaborations with outside institutions (such as Mayo Clinic and Johns Hopkins) ensuring that data is collected and entered in appropriate electronic records in a manner consistent between the institutions.
• Participates in the development of general goals for the Pediatric Oncology Research Team.
• Processes and ships biological specimens.
• Attends protocol meetings and other UIHC and Study Sponsor meetings; participates on committees as appropriate.
• Educates and trains faculty and staff on good clinical practices and regulations used in clinical research.
• Writes and implement corrective and preventative action plans for protocol deviations.
• Leads weekly meetings to update research team about the status of a study and to brainstorm solutions to issues and concerns the team is encountering.

About the Stead Family Department of Pediatrics

The Stead Family Department of Pediatrics is a national leader in pediatric medicine.  The Department's mission is to provide outstanding care to the children of Iowa and beyond by being a leader in state-of-the-art clinical care to children, performing cutting-edge research to find new treatments and cures for childhood illnesses, and educating the next generation of pediatric health care providers.  The Department comprises the medical and research staff of UI Stead Family Children’s Hospital.  UI Stead Family Children’s Hospital is one of the nation’s top-ranked pediatric care and research institutions, and Iowa’s only comprehensive children’s hospital.

Division of Pediatric Hematology/Oncology

The Division of Pediatric Hematology/Oncology at University of Iowa Children’s Hospital is a pioneer in the care and treatment of childhood cancers and blood disorders. It is part of the Holden Comprehensive Cancer Center, and a member of the Children’s Oncology Group (COG), a national consortium of pediatric cancer centers. The COG is well known for its new and innovative ways of treating childhood cancer. The division has a long history of success in bringing hope to patients with programs such as our blood and bone marrow transplant, comprehensive sickle cell program, and comprehensive hemophilia center.

The mission of the division is to treat and cure children and adolescents with cancer and blood diseases who live in Iowa by delivering personalized multidisciplinary, state-of-the-art care, through participation both in nationally and locally designed protocols.