Non-Therapeutic Registry

Cincinnati Children's

5d•$50,877 - $63,960

About The Position

Join the Oncology research team as a Clinical Research Coordinator supporting the International DIPG Registry, a collaborative effort focused on research into diffuse intrinsic pontine glioma (DIPG). The coordinator works with participating sites across the U.S. and internationally, supports day-to-day registry operations, facilitates data requests and data-sharing activities, and contributes to registry-based research projects. The role coordinates study activities, supports regulatory compliance and documentation, assists with participant recruitment, enrollment and retention, communicates with study teams and participants, and manages research data. The position also supports ethical and compliant human-participant research and contributes to improvements in study conduct.

Requirements

CRC II: High school diploma or equivalent and 2 years of work experience in a related job discipline.
CRC III: Bachelor’s degree in a related field and 1 year of directly related work experience, or a master’s degree in a related field.

Nice To Haves

Bachelor’s degree in a related field for CRC II.

Responsibilities

Assist with coordinating studies, preparing study personnel and materials, and preparing protocols, informed consents, amendments, and other documents for IRB and sponsor review.
Assemble lab kits and supplies; collect and label samples; and deliver, process, log, handle, and store specimens according to protocols, manuals, SOPs, and other work instructions.
Assist colleagues with implementing studies, maintain supply and equipment inventories, operate standard laboratory and research equipment when applicable, and troubleshoot equipment or erroneous results.
Identify and complete regulatory activities; assemble materials; maintain accurate written and electronic records; assist with audit readiness; and maintain protocol SOPs, IRB and regulatory correspondence, and regulatory binders.
Follow applicable federal, state, and local regulations, GCP/ICH, and institutional policies; report ethical or regulatory concerns to a supervisor; and seek research education opportunities.
Monitor the status of active studies, identify potentially eligible participants, and coordinate, plan, and conduct study visits, including providing participant instructions and reimbursement.
Approach potential participants and families professionally, conduct protocol-specific prescreening, review consent forms, carry out the informed-consent process, and communicate with participants’ clinical teams as indicated.
Document participants approached, screened, and enrolled in applicable tracking and electronic health systems; communicate recruitment and retention challenges and recommend improvements.
Organize and file correspondence, refer study questions and issues to appropriate team members, maintain awareness of study-related issues, and build rapport with participants.
Provide input in division discussions and participate in meetings and activities aimed at improving organizational performance and study conduct.
Complete case report forms and source documentation; review forms for completeness, accuracy, and GCP compliance; enter data into auditable databases or electronic data-capture systems; and maintain internal study records.
Verify source documentation, perform data quality checks, review reports, tables, and listings, and support data management, including responding to queries from data managers, statisticians, and sponsors.