Clinical Trials Research Assistant/Data Manager - Pediatrics Oncology at University of Iowa in Iowa City, Iowa
Posted in Other 3 days ago.
Job Description:
The UI Stead Family Department of Pediatrics is seeking a Pediatrics Clinical Trials Research Assistant to serve as a member of the Pediatric Oncology Research Team and assist in the planning, delivery and evaluation of health care provided to pediatric research protocol patients; work closely with Pediatrics 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. This is a specified term position.
Duties to include:
-
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.
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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.
o Assists in the accurate retrieval of basic study data as it pertains to laboratory specimens.
• Data Coordination:
o Create, populate, maintain, and enhance databases containing clinical and research information, ensuring compliance with IRB requirements.
o Identify and enter data into electronic databases from patient charts, lab reports, and study worksheets per protocol.
o Review and maintain completeness of protocol-required patient data.
o Support in resolving queries identified during study reviews.
o Obtain documentation of external hospitalizations or treatment reports from other facilities.
o Assist in reviewing treatment flow sheets and tools for source documentation.
• Laboratory Functions:
o Process and handle laboratory specimens according to study-specific instructions.
o Ensure proper storage and shipping of laboratory specimens.
o Inventory and order necessary laboratory kits per protocol requirements.
o Maintain cleanliness, operability, and safety of lab areas.
o Submit specimen and histology requisitions as required per protocol.
• Sponsor Monitoring and Communication:
o Coordinate with sponsors to schedule regular onsite and remote monitoring visits in accordance with sponsor requirements.
o Assists in the preparation of research study charts and other documents for routine review by both internal and external study monitors.
o Assist in follow-up of any queries identified during review.
o Support the research teams and regulatory personnel with sponsor requests during study opening and closing.
• Research Team Support/Additional Responsibilities:
o Attend research team meetings, protocol meetings, and participate in committees as necessary.
o Communicate timely updates on data collection and reporting needs.
o Assist pediatric research coordinators with various assigned tasks.
o Create worksheets and treatment flow sheets for protocol procedures.
o Assist in data validation, statistical analysis, and preparation of reports for review committees.
o Maintain documentation of protocols, correspondence, and study summaries.
o 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 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.
About the Division of 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.
Required Qualifications
- A 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.
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
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.
This position is eligible for a combination of on-campus (UIHC) and remote work. Remote work must be performed at an offsite location within the state of Iowa. 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. Work arrangement options will be discussed during the hiring process.
For additional questions, please contact Pediatrics Human Resources at pedsuichildrenshr@uiowa.edu
This position is not eligible for university sponsorship for employment authorization.
Additional Information
- Classification Title: Clin Trials Rsrch Asst/Data Mg
- Appointment Type: Professional and Scientific
- Schedule: Full-time
- Work Modality Options: Hybrid within Iowa
- Pay Level: 3a
- Organization: Healthcare
- Contact Name: Pediatric Human Resources
- Contact Email: Pedsuichildrenshr@healthcare.uiowa.edu
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