Vacancy for Regulatory Supervisor at Weill Cornell Medicine

Apply for the Vacancy for Regulatory Supervisor at Weill Cornell Medicine. The category of the position is Health and Medical Services.

Job Responsibilities

• Responsible for the day-to-day oversight of regulatory and administrative activities of the specified regulatory team(s). Together with the Regulatory Manager, recruits hires, supervises and trains regulatory staff.
• Also, the incumbent ensures completion of required training courses, perform probationary/annual evaluations, troubleshoot issues, and provide all other required administrative support.
• Likewise, he/she provides guidance on regulatory-related questions. Troubleshoots potential issues and facilitates smooth regulatory operations among the study team. Attends regulatory, management and staff meetings.
• Additionally, ensures consistent, timely and accurate completion of IRB applications/submissions and Clinical Study Evaluation Committee (CSEC) applications.
• Works with Regulatory Manager to develop standard operating procedures, workflows, regulatory processes and implement strategies to build and grow the regulatory team.
• Furthermore, he/she interfaces with program managers and regulatory staff to ensure that registrations and disenrollments are processed in an accurate and timely fashion for all studies.
• Liaises with satellite sites on regulatory tasks.
• Likewise, provides regulatory assistance as needed.

Qualifications

Education

• Bachelor’s Degree

Experience

• A minimum of 3 years of prior clinical research experience, or, a Master’s degree in a related field and 1 ½ year of prior clinical research experience.
• Also, knowledge of the Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations.
• Additionally, knowledge of the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines.
• Certified Clinical Research Professional (CCRP) preferred.
• Also, investigational New Drug experience (IND) preferred.

Knowledge, Skills, and Abilities

• Demonstrated excellent organizational, oral, and written communication skills.
• Also, the ability to foster smooth communications and teamwork among clinical research faculty, fellows, and staff as well as external organizations (sponsors and contract research organizations).
• Likewise, proficiency in MS Office, specifically word processing (Word), spreadsheets (Excel), and database applications.
• Demonstrated organizational skills and ability to pay close attention to detail.
• Demonstrated critical thinking and analytical skills.
• Also, the ability to multi-task and prioritize in a fast-paced environment.
• Demonstrated ability to remain focus despite frequent interruptions.
• Additionally, the ability to treat confidential information with the utmost discretion.

About

The Weill Cornell Graduate School of Medical Sciences is a graduate college of Cornell University that was founded in 1952 as an academic partnership between two major medical institutions in New York City: the Weill Cornell Medical College and the Sloan Kettering Institute.

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