Clinical Research Coordinator I… at Ann & Robert… · River…

Summary: Ann & Robert H. Lurie Children's Hospital of Chicago provides superior pediatric care and is seeking a Clinical Research Coordinator I to support clinical trials focusing on rare genetic disorders. The role involves assisting with study start-up, regulatory document preparation, and coordinating study activities with participants and research teams. Responsibilities: - Assists with study start-up and the preparation and maintenance of all regulatory documents required by sponsors and regulatory agencies (i.e. regulatory binders, source documents, correspondence, etc) - Assists with the preparation of protocols, informed consents, modifications, renewals and other necessary study documents for IRB and/or sponsor review - Assists clinical research personnel in the implementation of clinical research projects, assists in the identification and recruitment of eligible study subjects - Maintains inventory of study supplies and equipment - Prepares lab kits and requisitions prior to visits. Collects specimens from subjects and processes specimens as instructed - Helps arrange study visits and provide instructions to study participants and families - Coordinates reimbursement for study subjects - Helps triage patient questions - Assists with adverse event monitoring and reporting - Assists in creating and maintaining case report forms or source document templates - Abstracts data from medical records and enters information into study-specific forms and electronic data capture platforms - Facilitates study initiation, monitoring and close-out visits - May attend investigator meetings - Supports research activities by conducting literature searches, assisting with QA/AC procedures, entering, coding, creating, updating data spreadsheets, retrieving, preparing, and managing data through importing and exporting in various formats - Other job functions as assigned Required Qualifications: - Bachelor's degree required. A combination of education and/or experience may be considered in lieu of the degree when the experience is directly related to the duties of the job - Good organizational skills - Good verbal and written communications skills - Some knowledge of FDA, HSR, and GCP Guidelines - Proficient analytical skills with the ability to remain agile and adaptable to various technological systems - High School Diploma/GED: Biomedical Science (Required) Required Skills: Clinical research coordination, Regulatory document preparation, FDA guidelines, Health Services Research (HSR) guidelines, Clinical Practice (GCP) guidelines, Data abstraction, Electronic data capture platforms, Specimen collection and processing, Case report form creation, Quality assurance and quality control procedures Benefits: Medical, dental and vision insurance, Employer paid group term life and disability, Employer contribution toward Health Savings Account, Flexible Spending Accounts, Paid Time Off (PTO), Paid Holidays and Paid Parental Leave, 403(b) with a 5% employer match, Supplemental Life, AD&D and Disability, Critical Illness, Accident and Hospital Indemnity coverage, Tuition assistance, Student loan servicing and support, Adoption benefits, Backup Childcare and Eldercare, Employee Assistance Program, and other specialized behavioral health services and resources for employees and family members, Discount on services at Lurie Children’s facilities, Discount purchasing program