Clinical Research Assistant II-Neurosurgery

Strength Through Diversity Ground breaking science. Advancing medicine. Healing made personal. The Clinical Research Assistant II position will oversee regulatory compliance and IRB submissions for both the Academic Research Organization (ARO) and Local Affairs research teams in the Department of Neurosurgery. Responsibilities: Prepare IRB submissions including initial submissions, modifications, continuing reviews, protocol deviations, and adverse events Prepare internal submissions for research strategy committee review Provide support to other researchers and students by means of meetings and guidance Maintain regulatory files (ex. contracts, protocol signature pages, financial disclosures, training records, delegation of authority logs, etc.) for local and external sites Collaborate with local and external regulatory teams or project managers to maintain compliance on regulatory platform Review and approve the language in external sites’ consent forms Develop and maintain trackers to identify expiration dates of all regulatory documentation Ensure that all external sites have appropriate access to EDC and regulatory platform Draft site initiation reports and greenlight forms prior to site activation Collaborate with team on progress and annual report preparation to sponsors and FDA Education: Bachelor’s Degree Experience: 0-1 years of relevant clinical research experience Demonstrate strong ability to embrace and adapt to change, take initiative, showcase curiosity, and learn quickly in a fast-paced environment Able to successfully and productively work remotely. Strength Through Diversity The Mount Sinai Health System believes that diversity, equity and inclusion are drivers for excellence. We share a common devotion to delivering exceptional patient care. Yet we’re as diverse as the city we call home- culturally, ethically, in outlook and lifestyle. When you join us, you become a part of Mount Sinai’s unrivaled record of achievement, education, and advancement as we revolutionize medicine together and participate actively as a leader within the Mount Sinai Health System by: Serving as the primary resource management representative of the Mount Sinai leadership teams, committees, etc., and acting as the primary executive leader interface between Mount Sinai and key executives from the health systems’ vendors and partners. Engaging with relevant thought leaders and policy-makers at the federal and state levels, and representing the Health System as assigned. Using a lens of equity in establishing and promoting policies and procedures and providing opportunities for all to thrive. Confronting racist, sexist or other inappropriate behavior and challenges exclusionary organizational practices and serving as a role model to promote anti-racist behaviors. Inspiring and fostering an environment of anti-racist behaviors among and between departments and co-workers. We work hard to acquire and retain the best people, and to create a welcoming, nurturing work environment where you can develop professionally. We share the belief that all employees, regardless of job title or expertise, can make an impact on quality patient care. Explore more about this opportunity and how you can help us write a new chapter in our story! Who We Are Over 42,000 employees strong, the mission of the Mount Sinai Health System is to provide compassionate patient care with seamless coordination and to advance medicine through unrivaled education, research, and outreach in the many diverse communities we serve. Formed in September 2013, The Mount Sinai Health System combines the excellence of the Icahn School of Medicine at Mount Sinai with seven premier hospital campuses, including Mount Sinai Beth Israel, Mount Sinai Beth Israel Brooklyn, The Mount Sinai Hospital, Mount Sinai Queens, Mount Sinai West (formerly Mount Sinai Roosevelt), Mount Sinai Morningside (formerly Mount Sinai St. Luke’s), and New York Eye and Ear Infirmary of Mount Sinai. The Mount Sinai Health System is an equal opportunity employer. We comply with applicable Federal civil rights laws and does not discriminate, exclude, or treat people differently on the basis of race, color, national origin, age, religion, disability, sex, sexual orientation, gender identity, or gender expression. EOE Minorities/Women/Disabled/Veterans