Mount Sinai Medical Center
Regulatory Compliance Coordinator - Tisch Cancer Center
Mount Sinai Medical Center, New York, New York, us, 10261
Description
A Regulatory Compliance Coordinator position is currently available within the Tisch Cancer Institute. The incumbent will work with investigators and the Cancer Clinical Trials Office (CCTO) infrastructure to manage cancer clinical trials for the division. Duties include, but are not limited to, managing clinical studies through the regulatory portion of the trial submission process, ensuring regulatory integrity of assigned clinical trials from approval to closure, developing new clinical trials and acting as the main contact during the protocol development phase, corresponding with review committees and personnel, assisting in budget development by identifying research non‑billables, and coordinating startup meetings for new protocols. The position will report to the Manager of Regulatory. Individuals should be comfortable working in a team environment and will be expected to collaborate with investigators and administration. Cancer protocols include industry‑sponsored, consortium, NCI projects, and investigator‑initiated studies. The Tisch Cancer Institute is a vital component of the Mount Sinai Health System, a National Cancer Institute‑designated center that offers a multidisciplinary approach to cancer treatments and clinical breakthroughs. Responsibilities
Assist a multidisciplinary group of hematology/oncology principal investigators and researchers with the development of investigator‑initiated clinical trial protocols. Must understand complex scientific terminology and federal regulatory requirements. Create informed consent forms, case report forms, and additional study documents as needed per protocol. Develop and revise regulatory standard operating policies and procedures. Submit protocol applications for IRB review in a timely manner; track new protocols through the internal study startup committee system to approval and activation, responding to committee inquiries. Gather clinical and safety data to prepare and process applications for IRB annual renewal review and approval. Collaborate with the PI in completing required regulatory documents, including conflict of interest forms, delegation of authority logs, legal agreements, investigational pharmacy forms, serious adverse event forms, and more. Work with the Clinical Trials Manager to develop and ensure clinical trial regulatory compliance. Coordinate communication with investigators and research team to aid in study development and oversight throughout the clinical trial lifecycle. Participate in clinical trial feasibility, site selection, and site initiation visits, including conducting interviews with scientists, doctors, and academics. Submit IND applications and obtain FDA approval for investigator‑initiated trials. Act as the primary FDA contact for serious adverse events, amendments, annual reports, and other required submissions. Collaborate with the Financial Manager on study budget development, identifying billable versus research non‑billable procedures. Update and maintain clinicaltrials.gov records as mandated by FDA and NIH. Ensure proper regulatory compliance and maintain study‑specific regulatory binders. Assist auditors and committee members in assessing trial compliance. Act as liaison between the research team and the sponsor for clinical trial notices, updates, and monitoring visits. Mentor and train less experienced research staff, including coordinators and analysts. Perform other related duties as assigned. Qualifications
Bachelor’s Degree in health science, legal, or regulatory studies. 3+ years of direct experience in Regulatory Affairs, Clinical Affairs, or Quality Assurance within the medical device industry. Knowledge of Phase I‑IV clinical studies and data management aspects of clinical research. Working knowledge of Good Clinical Practice guidelines and Code of Federal Regulations. Oncology experience required; some medical knowledge preferred. Excellent written and oral communication skills. Strong analytical, organizational, and multitasking abilities. Proficiency in Microsoft Office programs (Word, Excel, PowerPoint, Outlook). Equal Opportunity Employer
The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. Compensation
The salary range for this role is $65,585.32 – $98,827.00 annually, which may vary based on experience, education, and operational needs.
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A Regulatory Compliance Coordinator position is currently available within the Tisch Cancer Institute. The incumbent will work with investigators and the Cancer Clinical Trials Office (CCTO) infrastructure to manage cancer clinical trials for the division. Duties include, but are not limited to, managing clinical studies through the regulatory portion of the trial submission process, ensuring regulatory integrity of assigned clinical trials from approval to closure, developing new clinical trials and acting as the main contact during the protocol development phase, corresponding with review committees and personnel, assisting in budget development by identifying research non‑billables, and coordinating startup meetings for new protocols. The position will report to the Manager of Regulatory. Individuals should be comfortable working in a team environment and will be expected to collaborate with investigators and administration. Cancer protocols include industry‑sponsored, consortium, NCI projects, and investigator‑initiated studies. The Tisch Cancer Institute is a vital component of the Mount Sinai Health System, a National Cancer Institute‑designated center that offers a multidisciplinary approach to cancer treatments and clinical breakthroughs. Responsibilities
Assist a multidisciplinary group of hematology/oncology principal investigators and researchers with the development of investigator‑initiated clinical trial protocols. Must understand complex scientific terminology and federal regulatory requirements. Create informed consent forms, case report forms, and additional study documents as needed per protocol. Develop and revise regulatory standard operating policies and procedures. Submit protocol applications for IRB review in a timely manner; track new protocols through the internal study startup committee system to approval and activation, responding to committee inquiries. Gather clinical and safety data to prepare and process applications for IRB annual renewal review and approval. Collaborate with the PI in completing required regulatory documents, including conflict of interest forms, delegation of authority logs, legal agreements, investigational pharmacy forms, serious adverse event forms, and more. Work with the Clinical Trials Manager to develop and ensure clinical trial regulatory compliance. Coordinate communication with investigators and research team to aid in study development and oversight throughout the clinical trial lifecycle. Participate in clinical trial feasibility, site selection, and site initiation visits, including conducting interviews with scientists, doctors, and academics. Submit IND applications and obtain FDA approval for investigator‑initiated trials. Act as the primary FDA contact for serious adverse events, amendments, annual reports, and other required submissions. Collaborate with the Financial Manager on study budget development, identifying billable versus research non‑billable procedures. Update and maintain clinicaltrials.gov records as mandated by FDA and NIH. Ensure proper regulatory compliance and maintain study‑specific regulatory binders. Assist auditors and committee members in assessing trial compliance. Act as liaison between the research team and the sponsor for clinical trial notices, updates, and monitoring visits. Mentor and train less experienced research staff, including coordinators and analysts. Perform other related duties as assigned. Qualifications
Bachelor’s Degree in health science, legal, or regulatory studies. 3+ years of direct experience in Regulatory Affairs, Clinical Affairs, or Quality Assurance within the medical device industry. Knowledge of Phase I‑IV clinical studies and data management aspects of clinical research. Working knowledge of Good Clinical Practice guidelines and Code of Federal Regulations. Oncology experience required; some medical knowledge preferred. Excellent written and oral communication skills. Strong analytical, organizational, and multitasking abilities. Proficiency in Microsoft Office programs (Word, Excel, PowerPoint, Outlook). Equal Opportunity Employer
The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. Compensation
The salary range for this role is $65,585.32 – $98,827.00 annually, which may vary based on experience, education, and operational needs.
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