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Clinical Trials Research Assistant/Data Manager

2 months ago

Iowa City, United States The University Of Iowa Full time

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.
  • 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.
oData Coordination

oAssists in the accurate retrieval of basic study data as it pertains to laboratory specimens.

•Data Coordination:

oCreate, populate, maintain, and enhance databases containing clinical and research information, ensuring compliance with IRB requirements.

oIdentify and enter data into electronic databases from patient charts, lab reports, and study worksheets per protocol.

oReview and maintain completeness of protocol-required patient data.

oSupport in resolving queries identified during study reviews.

oObtain documentation of external hospitalizations or treatment reports from other facilities.

oAssist in reviewing treatment flow sheets and tools for source documentation.

•Laboratory Functions:

oProcess and handle laboratory specimens according to study-specific instructions.

oEnsure proper storage and shipping of laboratory specimens.

oInventory and order necessary laboratory kits per protocol requirements.

oMaintain cleanliness, operability, and safety of lab areas.

oSubmit specimen and histology requisitions as required per protocol.

•Sponsor Monitoring and Communication:

oCoordinate with sponsors to schedule regular onsite and remote monitoring visits in accordance with sponsor requirements.

oAssists in the preparation of research study charts and other documents for routine review by both internal and external study monitors.

oAssist in follow-up of any queries identified during review.

oSupport the research teams and regulatory personnel with sponsor requests during study opening and closing.

•Research Team Support/Additional Responsibilities:

oAttend research team meetings, protocol meetings, and participate in committees as necessary.

oCommunicate timely updates on data collection and reporting needs.

oAssist pediatric research coordinators with various assigned tasks.

oCreate worksheets and treatment flow sheets for protocol procedures.

oAssist in data validation, statistical analysis, and preparation of reports for review committees.

oMaintain documentation of protocols, correspondence, and study summaries.

oPrepare 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

Job openings are posted for a minimum of 14 calendar 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.

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.