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 with sponsor requests during study opening and closing.

Research Team Support/Additional Responsibilities:

• 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.

About the Department of Pediatrics:

The Stead Family Department of Pediatrics is a national leader 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.

Education Requirement:

• Bachelor’s degree or an equivalent combination of education and experience

Experience Requirement:

• 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.

Desired Qualifications:

• 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

Position and Application Details:

In order to be considered for an interview, applicants must upload the following documents and mark them as a “Relevant File” to the submission.

• Resume
• Cover Letter

Job openings are posted for a minimum of 7calendar days and may be removed from posting and filled any time after the original posting period has ended.

Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification. Up to 5 professional references will be requested at a later step in the recruitment process.

For additional questions, please contact Pediatrics Human Resources at pedsuichildrenshr@uiowa.edu

This position is ineligible for University Sponsorship.

This position is eligible for a combination of on-campus and remote work. Remote work must be performed within Iowa and will require a work arrangement form to be completed upon the start of your employment. Per policy, work arrangements will be reviewed annually and must comply with the remote work program and related policies and employee travel policy when working at a remote location