Clinical Trials Research Associate - Cancer Center Iowa , IA

Overview

Clinical Trials Research Associate - Cancer Center job at University of Iowa. Iowa City, IA. 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.

• Functions as a member of the Clinical Research Services 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 information and in a manner that complies with Institutional Review Board requirements and in response to physician needs and research requirements.
• Assists in the design, development, execution and administration of data gathering and data entry for clinical trials.
• Communicates within team and with external stakeholders to convey study specific objectives and requirements; develops communication tools as necessary.
• Assists in the operations of clinical research studies including the screening, recruitment, enrolling of subjects; coordinates, randomizes and schedules subject assessments and treatment as required by protocol.
• Obtains informed consent; educates study participants on the scope of study and schedule of assessments for clinical trials and requirements of participation.
• Enters subject data on electronic databases ensuring that all prerequisites have been completed and are within the required parameters.
• 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.
• 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 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 protocol.
• 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 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).
• Assists in maintaining documentation of protocols and relevant data, follow-up correspondence, and summaries.
• Coordinates ongoing research collaborations with outside institutions and study sponsors ensuring that data is collected and entered in appropriate electronic records in a consistent and protocol defined manner.
• Reviews query reports and resolves all monitoring issues.
• Supports the disease specific team through providing back up for follow up patients as needed.

• Participates in the development of general goals for the Clinical Trials Support Services; recommends changes to work practices and policies to achieve desired outcomes.
• Ensures time, energy, learning opportunities, and actions are focused on creating a safe, fair and respectful work environment and improving the workplace.
• 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 principal investigator.

• Complies with University of Iowa policies and procedures.
• Maintains knowledge of departmental SOPs; ensure personal practice is in line with SOPs.
• Attends protocol meetings and other University of Iowa Health Care and Study Sponsor meetings; participates on committees as appropriate.
• Seeks professional development…