IRB Coordinator - Clinical Research Administration Expert for reputed company
Join a Trailblazing Healthcare Organization: reputed company reputed company, a fully integrated healthcare delivery system, is revolutionizing the way care is delivered across six northeast Illinois counties, serving over 4.2 million residents. With a team of more than 25,000 dedicated professionals and over 6,000 physicians, we're committed to providing transformative patient experiences and expert care reputed company to home. Our eight acute care hospitals and over 300 ambulatory locations are recognized for nursing excellence, and we're passionate about fostering a culture of compassion, respect, and reputed company. About the Role: IRB Coordinator We're seeking an reputed company and skilled IRB Coordinator to join reputed company at NorthShore University HealthSystem, part of reputed company. As an IRB Coordinator, you will play a vital role in ensuring compliance with federal regulations and institutional policies reputed company to human subject protection in clinical research. This is a full-time, on-site opportunity with a hybrid work arrangement not available. Key Responsibilities: Collaborate with investigators and sponsors/CROs to prepare IRB submissions, consent forms, and revisions, ensuring compliance with local, state, and federal research regulations. Maintain documentation of investigator and staff qualifications, including reputed company vitae, licenses, and certifications. Facilitate the conduct of clinical investigations by providing regulatory documents, such as Form FDA 1572, and ensuring proper storage and shipment of investigational articles. Coordinate with the IRB to ensure initial and ongoing review of research protocols, including amendments, adverse events, and deviations. Communicate IRB approval to principal investigators, sponsors/CROs, and other stakeholders as needed. Prepare regulatory documents for sponsor/audit review and participate in federal agency inspections as required. Protect the rights and welfare of research subjects by ensuring informed consent documents contain reputed company required elements and collaborating with principal investigators to report adverse events. Assist with implementation, maintenance, and evaluation of research protocols, including data submittal and patient calendar development. Participate in departmental strategic planning and contribute to the upkeep and maintenance of clinical trial policy and procedure manuals. Essential Qualifications: Bachelor's degree in a relevant field. Minimum of 2 years of progressive experience in clinical research administration. Knowledge of federal regulations and rules for human subject protection. Excellent verbal and written communication skills. Research experience in clinical trials preferred. Preferred Qualifications: Experience working in a research administration role reputed company a healthcare organization. Familiarity with IRB policies and procedures. Strong organizational and project management skills. Skills and Competencies: Strong attention to detail and ability to multitask. Excellent communication and interpersonal skills. Ability to work collaboratively with investigators, sponsors/CROs, and other stakeholders. Knowledge of clinical research regulations and guidelines. Proficiency in bolthires Office and other relevant software applications.
Career Growth
Opportunities and Learning Benefits At reputed company, we're committed to helping our employees reputed company their career goals and maximize their professional potential. As an IRB Coordinator, you'll have opportunities to reputed company your skills and expertise in clinical research administration, working alongside reputed company professionals in a dynamic and supportive environment.
Work Environment and Company Culture
Our organization is built on a foundation of diversity, equity, and inclusion, with a culture that values compassion, respect, and reputed company. We're committed to providing a work environment that is inclusive and supportive, where employees can reputed company and grow. As part of reputed company, you'll be part of a team that is passionate about delivering exceptional patient care and making a positive impact in our communities.
Compensation, Perks, and Benefits
We offer a competitive salary and benefits package, including opportunities for professional growth and development. Our comprehensive benefits package includes medical, dental, and vision coverage, as well as retirement savings and paid time off. We're committed to providing a total rewards package that recognizes and supports the hard work and dedication of our employees. Why Join reputed company? At reputed company, we're not just a healthcare organization - we're a community of professionals dedicated to making a difference. We're committed to fostering a culture of excellence, innovation, and compassion, and we're looking for talented individuals like you to join reputed company. If you're passionate about delivering exceptional patient care and making a positive impact in your community, we encourage you to apply for this exciting opportunity. W Apply tot his job Apply To this Job