ENT Clinical Trials Manager
3 weeks ago
Job Description
">We are seeking a highly skilled Clinical Research Coordinator to provide support to our clinical research studies. The successful candidate will work under the general direction of the PI and leadership within Chicago ENT, in accordance with established institutional policies and laboratory procedures.
Responsibilities
">- ">
- Aliquot and prepare experimental and clinical samples for freezing.">
- Ensure accurate storage for all specimen types.">
- Coordinate all aspects of conducting clinical trials including screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.">
- Recruit and interview potential study patients with guidance from PI and other clinical research staff.">
- Maintain accurate and complete documentation of signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRFs), and study-related communication.">
- Plan and coordinate patient schedule for study procedures, return visits, and study treatment schedules.">
- Perform experiments, collect, analyze, and interpret data under the supervision of the PI or designee.">
- Ensure Standard Operating Procedures (SOPs) are implemented and documented in accordance with study sponsor, primary investigator, and regulatory agency specifications.">
- Educate patients about study procedures to be performed, visit schedule, what to report between and during visits, and potential side effects.">
- Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.">
- Understand the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions independently.">
- Ensure compliance with federal regulations and institutional policies.">
- Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.">
- Participate in study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.">
- Identify new studies for participation through communication with sponsors and independent research by the coordinator.">
- Perform other related work as needed.">
Required Skills and Qualifications
">Education:
">Minimum requirements include vocational training, apprenticeships, or equivalent experience in a related field. A bachelor's degree is preferred.
">Work Experience:
">Minimum requirements include knowledge and skills developed through 1-5 years of work experience in a related job discipline.
">Certifications:
">GCP and IATA certifications are required.
">Preferred Competencies
">Professional working proficiency in Spanish is preferred.
">Experience with basic laboratory techniques, including centrifuging, aliquoting, measuring, pipetting, labeling, storing, and shipping.
">Eligible for hybrid work based on business needs and the demands of specific tasks. Working from the office is encouraged for tasks that require a high degree of collaboration.
">Rare travel required to attend sponsor/CRO meetings (< 5%).
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