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Clinical Research Manager
2 months ago
We are seeking a highly skilled and experienced MGR, Clinical Research to join our team at the Department of Medicine, Division of Infectious Diseases and Global Medicine.
Job Summary:The successful candidate will be responsible for managing all divisional regulatory tasks and clinical research management, providing leadership and direction for the division's clinical and human subject research portfolio.
Key Responsibilities:- Oversee the preparation and collation of all documentation required to support clinical trial applications, ensuring compliance with regulatory standards.
- Lead the preparation of IRB applications and maintain regulatory and IRB approvals throughout the project lifecycle.
- Direct the development and review of briefing documents to facilitate effective meetings with regulatory bodies.
- Coordinate the preparation and submission of annual reports, ensuring timely and accurate documentation.
- Manage updates to documentation in response to IRB or Regulatory comments and queries, ensuring all regulatory documents are current and compliant.
- Implement and maintain a comprehensive document filing system for easy access and historical tracking of documentation across projects.
- Supervise the renewal, re-registration, and submission of variations, amendments, and notifications, maintaining up-to-date regulatory status reports for all active projects.
- Master's degree in an appropriate area of specialization or a bachelor's degree in an appropriate area of specialization and two years of experience.
- Familiarity with regulatory documentation and clinical trials.
- Strong communication skills, good organization, detail-oriented, and familiarity with a medical environment.
We offer a competitive salary range of $70,000 - $92,200 and a comprehensive benefits package.
Please note that this is a time-limited position, and the application must be submitted by 11:55 p.m. (ET) of the posting end date.
The University is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information, and veteran status in all aspects of employment.
