Regulatory Specialist

Title: Regulatory Specialist Location: Upper East Side Org Unit: Regulatory Work Days: Weekly Hours: 35.00 Exemption Status: Non-Exempt Salary Range: $43.30 - $48.41 *As required under NYC Human Rights Law Int 1208‑2018 - Salary range for this role when Hired for NYC Offices Position Summary Oversees the clinical trial regulatory maintenance from study submission through closeout. Job Responsibilities Coordinates all aspects of protocol submission for research projects. Prepares and submits all necessary documents to the Clinical Science Evaluation Committee (CSEC), the Institutional Review Board (IRB) and ancillary committees. Works with the research team to facilitate the enrollment of research subjects in compliance with established regulations and guidelines. Reviews and confirms subject eligibility and regulatory compliance for enrollment. Submits eligibility exceptions to the IRB. Performs central subject registration for specified research studies. Reports all Serious Adverse Events (SAEs) to the Institutional Review Board and other agencies, as required. Prepares and submits all regulatory documents to sponsor and/or contract research organization (CRO). Ensures maintenance of up-to-date regulatory records and compliance with industry deadlines. Provides training to junior and new staff on subject registration and regulatory processes and procedures. Maintains and disseminates accurate listings of active and potential studies to participating investigators. Serves as the resource for detailed information on assigned protocols and other investigational research activities. Provides assistance for specified investigator-initiated trials. Coordinates site visits and audits of clinical trials. Attends conferences regarding clinical trials and disseminates information to clinical staff. Maintains electronic and hard copy files. Education Bachelor's Degree in related field Experience Approximately 2 years of prior clinical research experience in a healthcare setting. Master’s degree in a related field can be substituted for experience. Demonstrated knowledge and understanding of clinical research. Certified Clinical Research Professional (CCRP) Preferred Knowledge, Skills and Abilities Demonstrated strong communication and interpersonal skills; demonstrated ability to interact with multiple constituencies and exercise "people skills". Demonstrated proficiency with MS Office Suite and database applications. Demonstrated organizational skills and ability to pay close attention to detail. Demonstrated critical thinking and analytical skills. Demonstrated ability to multi-task and prioritize in a fast-paced environment. Demonstrated ability to remain focused despite frequent interruptions. Ability to treat confidential information with utmost discretion. Demonstrates ability to exercise standards of professionalism, including appearance, presentation and demeanor. Demonstrated ability to work effectively in a collaborative manner with all departmental faculty and staff, as well as other institutional representatives. Licenses and Certifications Working Conditions/Physical Demands Standard office work Cornell welcomes students, faculty, and staff with diverse backgrounds from across the globe to pursue world‑class education and career opportunities, to further the founding principle of “any person, any study.” No person shall be denied employment on the basis of any legally protected status or subjected to prohibited discrimination involving, but not limited to, such factors as race, ethnic or national origin, citizenship and immigration status, color, sex, pregnancy or pregnancy‑related conditions, age, creed, religion, actual or perceived disability (including persons associated with such a person), arrest and/or conviction record, military or veteran status, sexual orientation, gender expression and/or identity, an individual’s genetic information, domestic violence victim status, familial status, marital status, or any other characteristic protected by applicable federal, state, or local law. Cornell University embraces diversity in its workforce and seeks job candidates who will contribute to a climate that supports students, faculty, and staff of all identities and backgrounds. We hire based on merit, and encourage people from historically underrepresented and/or marginalized identities to apply. Consistent with federal law, Cornell engages in affirmative action in employment for qualified protected veterans as defined in the Vietnam Era Veterans’ Readjustment Assistance Act (VEVRRA) and qualified individuals with disabilities under Section 503 of the Rehabilitation Act. We also recognize a lawful preference in employment practices for Native Americans living on or near Indian reservations in accordance with applicable law. #J-18808-Ljbffr Weill Cornell Medical College