About the position The UI Stead Family Department of Pediatrics division of Hematology/Oncology is seeking to hire a Clinical Trials Research Assistant/Data Manager (PRV1) at 100% effort. This person 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 position is a Specified Term appointment.

Responsibilities

• Participates in the development of general goals for the Pediatric oncology research team.
• Conducts all work in a manner that complies with Institutional Review Board requirements, departmental SOPs, and in response to physician and research needs and requirements.
• Assist in the operations of clinical research studies, including recruitment, coordination, and scheduling of subject participation.
• Follow study participants, manage data collection during visits, and maintain records of patient visits/interviews.
• Obtain all clinical assessments (For Example: ECGs) during study visits as listed per protocol.
• Assist in obtaining and delivering prescription medications from investigational pharmacy.
• Accompany patients and provide transportation to other departments, as necessary.
• Serve as liaison to local physicians/hospitals for protocol patients at outside institutions.
• Assists in the accurate retrieval of basic study data as it pertains to laboratory specimens.
• Create, populate, maintain, and enhance databases containing clinical and research information, ensuring compliance with IRB requirements.
• Identify and enter data into electronic databases from patient charts, lab reports, and study worksheets per protocol.
• Review and maintain completeness of protocol-required patient data.
• Support in resolving queries identified during study reviews.
• Obtain documentation of external hospitalizations or treatment reports from other facilities.
• Assist in reviewing treatment flow sheets and tools for source documentation.
• Process and handle laboratory specimens according to study-specific instructions.
• Ensure proper storage and shipping of laboratory specimens.
• Inventory and order necessary laboratory kits per protocol requirements.
• Maintain cleanliness, operability, and safety of lab areas.
• Submit specimen and histology requisitions as required per protocol.
• Coordinate with sponsors to schedule regular onsite and remote monitoring visits in accordance with sponsor requirements.
• Assists in the preparation of research study charts and other documents for routine review by both internal and external study monitors.
• Assist in follow-up of any queries identified during review.
• Support the research teams and regulatory personnel with sponsor requests during study opening and closing.
• Attend research team meetings, protocol meetings, and participate in committees as necessary.
• Communicate timely updates on data collection and reporting needs.
• Assist pediatric research coordinators with various assigned tasks.
• Create worksheets and treatment flow sheets for protocol procedures.
• Assist in data validation, statistical analysis, and preparation of reports for review committees.
• Maintain documentation of protocols, correspondence, and study summaries.
• Prepare materials for reports on various oncology protocols and compile summary data for analysis.

Requirements

• Bachelor’s degree or an equivalent combination of education and experience
• 6 to 12 months experience in a research or health care setting
• Experience with medical terminology
• Excellent verbal, written and interpersonal communication skills.
• Proficient in computer software applications
• Ability to manage complex information with attention to detail and a high level of accuracy.

Nice-to-haves

• Relevant experience in the conduct of clinical or laboratory research studies
• Knowledge of regulatory guidelines and procedures
• Clinical Research Coordinator Certification (SOCRA or ACRP)
• Certification that allows for blood draw (Phlebotomy Technician, Certified Medical Assistant, LPN)
• Experience conducting electrocardiograms (ECG)
• Experience working with Epic
• Knowledge of University of Iowa policies, procedures, and regulations

Benefits

• Specified Term appointment