This job was posted by https://illinoisjoblink.illinois.gov : For moreinformation, please see:https://illinoisjoblink.illinois.gov/jobs/11607403 Department

　　BSD MED - Gastroenterology - Clinical Research Staff

　　About the Department

　　The Section of Gastroenterology, Hepatology at The University of Chicagois consistently ranked among the best specialty nationally by U.S Newsand World Report. With nearly 30 specialists on staff, our program playsa leading role in the understanding of digestive diseases and indeveloping innovative and successful treatments for patients. Sinceforming the nation\'s first full-time department of gastroenterology in1927, our physicians have continually improved treatments for digestivetract and related disorders by combining medical research, education,and patient care at the highest level.

　　Job Summary

　　The Clinical Research Coordinator 2 (CRC2) is a specialized researcherpartnering with the clinical Principal Investigator (PI) and under thedirection of the Clinical Research Manager in the Section ofGastroenterology in the Department of Medicine.

　　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.

　　Protect 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.

　　Responsibilities may include the following non-laboratory duties:May assist in recruiting and scheduling research subjects; assistingwith developing or amending study protocols; assisting withdeveloping data collection tools; assisting with building databases;and providing general administrative support.

　　Responsibilities may include the following laboratory duties:setting up and performing experiments; interacting with students andother laboratory staff under the direction of the principalinvestigator.

　　Analyzes protocols and advise treating physicians on appropriatedosage modifications or treatment calculations based on patientcharacteristics.

　　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.

　　---

　　Work Experience:

　　Minimum requirements include knowledge and skills developed through---

　　Certifications:

　　---

　　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

　　Abi