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　　BSD MED - Hematology and Oncology - Clinical Research Staff - Cluster 7

　　About the Department

　　The Section of Hematology/Oncology has a proud and long tradition ofexcellence in research-based patient care and clinical discovery. Rankedamong the finest cancer programs in the country, the Section iscomprised of nationally and internationally known faculty with expertisein all major types of malignancies, blood disorders, and experimentaltherapies.

　　Job Summary

　　The Clinical Research Coordinator 2 (CRC2) is a specialized researcherpartnering with the Clinical Principal Investigator (PI) and under thedirection of a departmental or lab research manager. While the PrincipalInvestigator is primarily responsible for the overall design, conduct,and management of the clinical trial, the CRC2 supports, facilitates andcoordinates independently the daily clinical trial activities and playsa critical role in the conduct of the study.

　　By performing these duties with limited supervision and/or guidance, theCRC2 works with the PI, department, sponsor, and institution to supportand provide guidance on the administration of the compliance, financial,personnel and other related aspects of the clinical study.

　　Responsibilities

　　Manages all aspects of conducting clinical trials including:screening, enrollment, subject follow-up, completion of the casereport form, and adverse event reports.Recruits and interviews potential study patients with guidance fromPI and other clinical research staff.Collects, processes, ships and stores specimens to appropriatelaboratory according to established aseptic techniques.Identifies and explains the responsibilities of PrincipalInvestigators, research team members, sponsors, contract researchorganizations (CROs), and regulatory authorities related to theconduct of a clinical trial.Coordinates the conduct of the study from startup through closeoutincluding recruitment and screening of study subjects, obtaininginformed consent, collecting research data, and ensuring protocoladherence.Plans and coordinates patient schedule for study procedures, returnvisits, and study treatment schedules.Educates patients about study procedures to be performed, visitschedule, what to report between and during visits, and the risksand benefits of the procedures.Performs assessments at visits and monitors for adverse events.Organizes and attends site visits from sponsors and other relevantstudy meetings.Protects patients\' and data confidentiality by ensuring security ofresearch data and personal health information and compliance withfederal regulations and sponsor protocols.Ensures Standard Operating Procedures (SOP) are implemented anddocumented in accordance to study sponsor, primary investigator, andregulatory agency specifications.Maintains accurate and complete records which may include, but arenot limited to, signed informed consent, relevant IRB approvals,source documentation, Case Report Forms (CRF\'s), drug dispensinglogs, and study related communication.Understands the IRB submission and review process and when and howto apply for IRB review, including facilitation of study initiationthrough meticulous and timely preparation of IRB submissionsindependently.Ensures compliance with federal regulations and institutionalpolicies.May prepare and maintain protocol submissions and revisions.May assist in the training of new or backup coordinators.Coordinates and may participate in quality assurance reviewsconducted by study sponsors, federal agencies, or speciall designated review groups.Analyzes study-related documentation, such as protocol worksheets,procedural manuals, adverse event reports, institutional reviewboard documents, or progress reports.Performs other related work as needed.Minimum Qualifications

　　Education:

　　Minimum requirements include a college or university degree in relatedfield.

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　　Work Experience:

　　Minimum requirements include knowledge and skills developed through---

　　Certifications:

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　　Preferred Qualifications

　　Education:

　　Bachelors degree.Experience:

　　Clinical research experience or relevant experience.Experience coordinating multiple studies (e.g., investigatorinitiated, industry sponsored, multi-site trials).Preferred Competencies

　　Aware of safety hazards and take appropriate precautions.

　　Communicate in writing.

　　Communicate orally.

　　Comprehend technical documents.

　　Condense complicated issues to simple summaries that can be understoodby a variety of cons