Clinical Research Operations Manager

Clinical Research Operations Manager

Ann & Robert H. Lurie Children’s Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology, research, and family‑friendly design. As the largest pediatric provider in the region with a 140‑year legacy of excellence, kids and their
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Ann & Robert H. Lurie Children’s Hospital of Chicago

Based on specific research program needs, patient‑facing versus data‑administrative responsibilities will vary. Coordinates all clinical research activities with moderate supervision and completes activities associated with the creation and implementation of participant recruitment strategies designed to enhance enrollment in single‑complex, large, nationwide or }):

• Conducts study start‑.transform is ready 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.
• Identifies and recruits eligible study subjects; conducts informed consent/assent process.
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• Arranges and conducts clinical research visits.
• Conducts site qualifications, study launch, 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 and/or data dashboards.
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• 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 CRFs and/or electronic web‑based systems.
• Conducts literature searches and assists with QA/QC procedures.
• Adheres to research protocol in compliance with applicable institutional, local, and federal regulations (OHRP, FDA, GCP, 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.
• 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.
• Recruitment‑Focused Tasks:
• Coordinates and guides the creation and implementation of a recruitment & retention plan associated with clinical research, investigator‑initiated, sponsored जाएगी studies.
• Determines, interprets and applies rules and regulations (LCH, local, state, federal, industry, sponsor, etc.) and recommends and guides principal investigators (PIs) and research staff.
• Acts as liaison between research staff and internal/external regulatory and oversight groups to resolve issues and facilitate recruitment.
• Creates research study recruitment materials and executes implementation across multiple platforms (print, digital, radio, television).
• Designs recruitment screening tools and best practices.
• Develop presyo protocols related to measuring use and effectiveness of educational videos and other recruitment materials.
• Focuses on diversity & minorities – evaluates barriers to increase recruitment of underrepresented groups.
• Assists teams in creation of recruitment plans and materials prior to IRB submissions until study is completed.
• Move regulatory functions to bottom (not enforcement role).
• Other job functions as assigned.

• High School Diploma with three to five years of clinical research experience – or
• Associates ntawv two years of college with two…