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