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Dept-015 Tisch Cancer Institute REQ #2495410
Job Title: Regulatory Compliance Coordinator
A Regulatory Compliance Coordinator position is currently available within the Tisch Cancer Institute. The position will report into the Manager of Regulatory and will provide support in managing cancer clinical trials for the Center for Thoracic Oncology division. The Regulatory Compliance Coordinator will is be responsible for clinical studies through the regulatory portion of the trial submission process to maintaining the regulatory integrity of assigned clinical trials from approval to closure.
The Center for Thoracic Oncology has the goal of ensuring best quality care of patients with Lung Cancer and enhance research in the field of Lung Cancer and other thoracic malignancies.
The Tisch Cancer Institute is a vital component of the Icahn School of Medicine at Mount Sinai Hospital and plays a key role in the Mount Sinai Health System, which is one of the largest health care systems in the nation. We are a National Cancer Institute (NCI)-designated center and provide a multidisciplinary approach to cancer treatments and clinical breakthroughs that may one day put an end to cancer.
- Provides regulatory support to clinical trial project teams.
- Liaises with sponsors, investigators and team members, providing trial information and updates as required in written, oral and meeting format, adhering to appropriate timelines
- Develops and/or revises regulatory policies and procedures.
- Submits application in a timely manner; responds to comments, questions and requests for clarification by IRB review by stated guidelines
- Participates in Study Initiation Visits and Interim Monitoring Visits
- Ensures proper regulatory compliance in accordance with sponsoring agency requirements
- Maintains study specific regulatory binder
- Performs other duties as assigned
- Bachelor’s Degree preferably in science.
- A minimum of 3 years of research experience in Regulatory Affairs, Clinical Affairs or Quality Assurance.
- Exposure to clinical research in an academic setting.
- Excellent written and oral communication skills
- Analytical skills for problem solving; attention to detail and accuracy
- Ability to manage multiple tasks & priorities
- Working knowledge Good Clinical Practice guidelines and Federal research regulations. Demonstrate strong organizational and communication skills.
- Oncology experience preferred