Clinical Trials Research Asst/Data Manager - Children's Oncology Group

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. 

Position Responsibilities:

General 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.

Patient Coordination:

• 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.
• Data Coordination
• Assists in the accurate retrieval of basic study data as it pertains to laboratory specimens

Data Coordination:

• 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.

Laboratory Functions:

• 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.

Sponsor Monitoring and Communication:

• 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 wit