Clinical Project Managers

About the role

The Division of Hematology, Oncology, BMT has an immediate opening for a Clinical Project Manager in the Department of Pediatrics at the University of Utah Spencer F. Eccles School of Medicine. This position will be responsible to coordinate all aspects of clinical studies from after study initiation for the pediatric oncology team.

Responsibilities

• Cook up all aspects of clinical studies after study initiation for the pediatric oncology team.
• Prepare study-related documentation such as approved informed consent documents, quality of life questionnaires, and laboratory orders, according to the protocol.
• Maintain required records and ensure compliance with protocols, regulatory regulations, and overall clinical objectives.
• Record patient registration in management systems, including EPIC, Oncore, RedCap, and iMedidata Rave.
• Utilize project management methodologies, coordinate with cross-functional teams, resolve issues within the clinical study, and ensure that all targets, timelines, budgets, and requirements are met.
• Cook up patient recruitment, eligibility verification, informed consent, and registration for clinical trials in collaboration with the attending physician and study team.
• Prepare and maintain all required study documentation for newly enrolled patients, including consent forms, eligibility criteria, and pre-treatment requirements.
• Cook up the collection, processing, and shipment of protocol-required specimens, pathology materials, imaging, and quality of life surveys in accordance with study guidelines and regulatory requirements.
• Ensure accurate and timely preparation of treatment roadmaps and conduct daily reviews of clinic schedules to support patient care; assist clinical staff in obtaining current treatment plans for inpatient and outpatient settings.
• Oversee protocol compliance, including quality control, documentation accuracy, identification and reporting of protocol deviations, and preparation of required reports for regulatory agencies and sponsoring organizations.
• Facilitate communication between physician investigators, study sponsors, and coordinating centers; assist with study-related correspondence and issue resolution.
• Ensure accurate routing of research-related charges in accordance with institutional and study-specific billing requirements.
• Prepare for and support internal and external audits, site visits, and peer reviews by maintaining complete and accurate regulatory and study documentation.
• Provide cross-coverage and support for team functions as needed; perform additional duties as assigned.
• Ensure the accuracy, completeness, and timeliness of clinical trial data by performing data entry, validation, and reconciliation across source documents and EDC systems; proactively manage and resolve data queries; and support audit readiness through high-quality, inspection-ready documentation.

  Qualifications

  • EQUIVALENCY STATEMENT : 1 year of higher education can be substituted for 1 year of directly related work experience (Example: bachelor’s degree = 4 years of directly related work experience).
  • At least 2 years of directly related work experience (or equivalency).
  • ACRP / SOCRA Certification.