Why join our world-class team? Because at Ann & Robert H. Lurie Children's Hospital, we're committed to providing superior pediatric care with the most advanced innovations in medical technology. We offer cutting-edge research, education for physicians, nurses, and allied health professionals; and a family-friendly environment. Some amazing kids are counting on you! Join our team as: Lead Clinical Research Coordinator-Emergency Medicine Full-time Day-Evening Shift The strong communicator we select for this important role will collaborate with PI, while functioning independently. This individual will be accountable for the complete coordination of assigned clinical research activities and may supervise an associated study staff. Responsibilities may include: - Conducting study start-up activities and preparing and maintaining all regulatory documents required by the sponsor and/or regulatory agencies.
- Preparing protocols, informed consent documents, modifications, renewals and other necessary documents for review by the IRB and/or sponsor.
- Coordinating study conduct with other departments to effectively implement clinical research projects; obtaining required letters of support and/or approvals (i.e., IBC and SRC); and ensuring that protocol is followed.
- Identifying and recruiting eligible study subjects; and conducting informed consent/assent process.
- Conducting site qualifications, study initiation, monitoring and/or close-out visits.
- Abstracting data from medical records and entering medical information/data onto protocol-specific case report forms, study flow sheets, and other required study forms; and preparing abstracted/coded data for processing/analysis.
- Creating and/or updating case report forms and/or source document templates.
- Coordinating multiple and/or more complex clinical research protocols.
- Assisting in the preparation of budgets and fund management.
- Assisting in the conduct of statistical analysis.
- Functioning as a mentor/resource to other CRPs.
- Building codebooks for data dictionaries.
- Preparing and negotiating budgets with sponsors; providing oversight of study charges to fund accounts; and ensuring timely and accurate invoicing.
- Leading the development, implementation and evaluation of multiple or complex clinical research studies.
- Performing independent statistical analysis of clinical research data at a basic level or working with study statistician on analysis (SPSS, SAS, Stata).
- Preparing manuscripts for publication and other presentations.
Credentials - Bachelor's degree with five or years of clinical research experience required.
- Leadership experience preferred.
- Strong analytical, organizational, and customer service skills essential.
- Strong verbal and written communication skills essential to addressing large and diverse audiences a must.
- Demonstrated working knowledge of regulatory practices required.
- Certification as a Clinical Research Professional (SOCRA) or Clinical Research Coordinator (ACRP) required.
- Proficiency with advanced Excel formulas, including VLOOKUP and COUNTIF/IF essential.
- Proficiency with pivot tables required.
Enjoy our highly competitive compensation and rewards package. To learn more about us and apply, please visit our site at: luriechildrens.org/careers Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color or any other protected class. EEO/AA Employer/Vets/Disability |