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Clinical Research Coordinator II - Peoria, Illinois (Onsite)
Coordinate clinical trials for Carle Health in Peoria, Illinois, including patient enrollment, informed consent, study data, and regulatory documentation. Support compliant research operations across patient-care settings.
विवरण
- Uphold Good Clinical Practice standards throughout clinical investigations
- Ensure compliance with study protocols and applicable regulatory requirements
- Review technical operations and quality-control processes, protocols, and procedures
- Coordinate assigned research studies across acuity levels within the scope of licensure
- Design forms and source-document tools for implementing study protocols
- Record protocol deviations and exemptions
- Collect, review, abstract, record, correct, and maintain source documents and case report form data
- Enter and transmit electronic study data and resolve data queries
- Maintain study-article dispensing logs and study files
- Prepare case report forms and source documents for sponsor and audit reviews
- Track enrollment targets and adjust recruitment plans when necessary
- Maintain screening and enrollment logs while clinically following participant populations
- Review eligibility criteria and required medical-record documentation with investigators
- Explain study protocols, informed-consent forms, and follow-up procedures to prospective participants
- Interview participants and obtain informed consent before study procedures
- Apply randomization procedures and oversee study-article administration
- Schedule follow-up visits and review participant diaries and questionnaires
- Coordinate specimen collection, batching, and shipment
- Evaluate participant compliance and report laboratory values or alerts to investigators and sponsors
- Safeguard patient privacy and securely retain or dispose of sensitive documents
- Communicate with participants, research teams, IRBs, sponsors, CROs, primary care providers, and monitors
- Submit protocol amendments, progress reports, regulatory materials, and adverse-event notifications on schedule
- Arrange and participate in sponsor monitoring visits
- Resolve questions about enrollment, sponsor expectations, and study procedures with investigators and sponsors
- Coordinate proposed clinical trials with ongoing research activities
- Attend investigator meetings and verify required approvals and informed-consent documents before study launch
- Educate patients about study medication or device use
- Advise management on incorporating research operations into clinic workflows
आवश्यकताएँ
- Coordinate assigned research studies within the scope of licensure
- Demonstrate thorough knowledge of federal clinical-trial regulations and human-subject protection guidance
- Understand Good Clinical Practice, applicable local, state, and federal laws, regulations, guidance, policies, and procedures
- Know Institutional Review Board requirements, FDA Code of Federal Regulations provisions, and International Conference on Harmonization standards
- High school diploma or GED
- Bachelor's degree in a related field identified in the education requirements
- Obtain Certified Clinical Research Coordinator certification through the Association of Clinical Research Professionals within 2.5 years
- Complete sponsor protocol training covering GCP, EDC, IVRS, and IRB processes
- Conduct informed consent, evaluate participant eligibility, and follow study protocols
- Collect, document, maintain, and transmit accurate clinical-trial data and source records
लाभ
- Comprehensive benefits package
- Equal Opportunity Employer
- Opportunities for professional growth and long-term career development
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