Clinical Research Operations
Clinical research operations provide a comprehensive range of services to support clinical research across Carle Health, ensuring ethical, safe, and compliant execution of all patient-engaged research studies and clinical trials. Our expert coordinators have extensive experience with pharmaceutical and device trials, federally funded and investigator-initiated trials across multiple diseases and conditions.
Services
We are committed to supporting research across a wide spectrum of medical disciplines. Whether it's a specialized field with existing infrastructure or an emerging area of medical interest, we collaborate with healthcare professionals to bridge the gap. By leveraging our expertise in research coordination, regulatory navigation and protocol development, we enable innovative investigations in all clinical areas.
Staff are trained in:
- Basic clinical skills (vital signs, phlebotomy).
- Clinical Trials Management System.
- EPIC.
- Good Clinical Practice.
- Human subjects protection.
- SOCRA certification is required after two years of experience.
Support services are provided as a fee-for-service program to investigators for their funded research projects.
Clinical Research Coordination
Our clinical research coordinators are committed to ensuring the seamless execution of research projects. From patient recruitment and enrollment to data collection and management, our experts provide meticulous oversight at every stage of the process. They’re responsible for managing the day-to-day activities of the research program, ensuring smooth communication between all stakeholders and maintaining compliance with established protocols.
Research coordinators oversee patient recruitment, screening and the informed consent process, guaranteeing that all participants meet the necessary criteria and make well-informed decisions about their participation. They adhere to strict standards of accuracy, confidentiality, ethics, and timeliness.
Coordinators have established research workflows with:
- Pharmacy.
- Lab and Pathology.
- Imaging.
- Infusion.
- Inpatient care.
Contacts
Oncology: Betsy Barnick, Clinical Research Manager
Neuroscience and Cardiovascular: Carly Skadden, Clinical Research Manager
Peoria area: Savannah Hammerl, Clinical Research Manager
All other programs: Christine Canfield, Clinical Research Manager
Regulatory Affairs
Regulatory affairs specialists play a vital role in ensuring the compliance and ethical integrity of clinical research projects. Their responsibilities encompass a range of tasks aimed at meeting regulatory, Institutional Review Board (IRB) and Health Insurance Portability and Accountability Act (HIPAA) guidelines and policies. They act as a critical liaison between the research team, regulatory bodies, sponsors, and institutional guidelines. Their role involves meticulous document management, compliance with regulations, and maintaining ethical standards throughout the lifecycle of clinical research projects.
To Clinical Trials Business Office
Contracting and Agreements
All research contracts and agreements must be negotiated by designated sponsored projects staff on behalf of the organization. The Vice President for Research is the designated institutional official for federal research agreements and Human Subjects Protection. Please contact the appropriate clinical research manager with questions about the required agreements for collaborative projects. The following types of agreements may be required depending on project scope:
- Confidentiality and nondisclosure agreements
- Clinical trial agreements
- Primary and subaward agreements
- Research service agreements
- Research collaboration agreements
- Material transfer agreements
- Data use agreements
To Grants Administration Office
Clinical Trials Finance
The Clinical Research Finance team is responsible for conducting thorough financial assessments, developing accurate budgets, ensuring billing compliance and managing financial interactions with industry sponsors. Their activities contribute to the financial success of clinical trials while upholding the organization's commitment to regulatory compliance and ethical research practices.
To Clinical Trials Business Office
Human Subjects Protection Program
HSPP and the Institutional Review Board ensure the rights and welfare of research participants and promote excellence in human subjects research.
To Human Subjects Protection Program
Specimen Procurement Services
Access to high-quality specimens is fundamental to advancing medical research. We offer a streamlined process for procuring various biological specimens, including tissue and blood samples, maintaining strict adherence to ethical guidelines and quality control standards.
To Specimen Procurement Service Center
Research Protocol Development
Crafting a robust research protocol is the foundation of any successful study. Our team of seasoned researchers collaborates with you to develop comprehensive and meticulously designed research protocols, setting the stage for meaningful outcomes.
To Investigator Initiated Research Services
Research Partner and Clinical Collaborator Connections
Collaboration is key in driving medical progress. Our program serves as a dynamic hub that connects research partners with clinical collaborators, fostering interdisciplinary interactions that amplify the impact of your research endeavors.