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Ann & Robert H. Lurie Children's Hospital of Chica Clinical Research Coordinator II - Cardiology in Chicago, Illinois

Based on specific research program needs, patient facing vs. data administrative responsibilities will vary. Coordinates all clinical research activities with moderate supervision.

  • Conducts study start-up activities and prepares and maintains all regulatory documents required by sponsor and/or regulatory agencies.

  • Prepares protocols, informed consent documents, modifications, renewals and other necessary documents for review by the IRB and/or sponsor.

  • Coordinates study conduct with other departments to effectively implement clinical research projects; obtains required letters of support and/or approvals as needed (i.e. IBC, SRC, etc.) and protocol is followed.

  • Identifies and recruits eligible study subjects; conducts informed consent/assent process.

  • Arranges and conducts clinical research visits.

  • Conducts site qualifications, study initiation, monitoring and/or close-out visits.

  • Attends investigator meetings.

  • Abstracts data from medical records and enters medical information/data onto protocol specific case report forms, study flow sheets, and other required study forms; prepares abstracted/coded data for processing/analysis.

  • Creates and/or updates case report forms and/or source document templates.

  • Coordinates reimbursement of subjects.

  • Maintains inventory of supplies/equipment.

  • Prepares lab kits and requisitions prior to visits.

  • Collects specimens from subjects and processes specimens or works with Research lab to ensure samples are processed/sent out correctly.

  • Records data on source documents and CRF’s and/or electronic web based systems.

  • Conducts literature searches and assists with QA/QC procedures.

  • Monitors/assesses adverse events and reports them as required.

  • Adheres to research protocol in compliance with applicable institutional, local and federal regulations (OHRP, FDA, GCP, etc.).

  • Functions as patient liaison for study questions, billing issues, etc.

  • Maintains all study documents (regulatory binders, source documents, correspondence, etc.).

  • Promotes the ethical conduct of research by actively participating in research related educational meetings/conferences (planning, presenting, etc.).

  • Performs job functions adhering to service principles with customer service focus of innovation, service excellence and teamwork to provide the highest quality care and service to our patients.

  • QA/QC checks for database validity and data monitoring.

  • Tracking deadlines for grants/deliverables.

  • High School Diploma with three to five years research experience -or- Associates /two years of College with two to four years research experience –or-Bachelors with one to three years research experience.

  • Knowledge of research regulations (FDA, OHRP, GCP, etc.) preferred.

  • Good clinical practices documentation required.

  • Familiarity and experience with FDA and IRB regulatory requirements preferred.

Requisition ID: 2020-14271

Shift: Days

Street: 211 E Chicago Ave