Regulatory Compliance Coordinator Tisch Cancer Center

A Regulatory Compliance Coordinator position is currently available within the Tisch Cancer Center. 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 management of clinical studies through the regulatory portion of the trial submission process ensuring regulatory integrity of assigned clinical trials from approval to closure develop new clinical trials and act as the main contact during the protocol development phase correspond with the reviewing committees and personnel assist in budget development by identifying research non-billables and coordinate start-up meetings for new protocols. The position will report into the Manager of Regulatory

Individuals should be comfortable with working in a team environment and will be expected to work collaboratively with investigators and administration. Cancer protocols include industry-sponsored consortium NCI projects and investigator-initiated studies.

The Tisch Cancer Center is a vital component of 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.

• Protocol development: Provides regulatory support to clinical trial project teams. Work with investigators to create new protocols informed consent forms case report forms and additional study documents as needed per protocol.
• Develops and/or revises regulatory policies and procedures.
• Submits protocol applications for IRB review in a timely manner; tracks new protocols through the committee system to approval responds to committees inquiries for clarification
• Gathers data needed to prepare and process applications for IRB review and approval.
• Collaborates with the Principal Investigator (PI) in completion of application documents including all required PPHS paperwork for approval of new clinical research trials.
• Collaborates with the Clinical Trials Manager in developing and ensuring regulatory compliance with respect to clinical trials.
• Coordinates conference calls with investigators to aid in study development.
• Participate in Clinical Trial Feasibility Site Selection Process and the Site Initiation Visit which includes conducting interviews with scientists doctors and academics and others in a network of industry experts.
• Obtains IND# for the clinical trials through correspondence with the FDA and submission of paperwork necessary to obtain an IND#.
• Collaborates with the Financial Manager on the development of the study budget (as needed); identifies billable versus research non-billable tests for the budget.
• Updates and maintains records of protocols on website. Analyzes moderate to complex clinical research data related to i.e. oncology immunology microbiology etc; Assists in interpreting clinical research data used in scientific publication. Must have strong science background.
• Coordinates the communication of protocol sites including: protocol approvals and the distribution of all applications to investigators and other departments.
• Upon protocol approval transitions the protocol to be implemented by investigator(s) program manager(s) clinical research coordinator(s) regulatory coordinator(s) and research nurse(s).
• Organizes and conducts start-up meetings for new protocols.
• Ensures proper regulatory compliance in accordance with sponsoring agency requirements. Maintains study specific regulatory binder(s).
• Works with auditors and auditory committees to assess trial compliance and related issues.
• Able to read and understand scientific pre-clinical data being applied to conduct clinical trials. Prompt PIs and Research RNs about protocol requirements for upcoming study visits.
• Mentors and trains less experienced staff including Clinical Research Coordinators.
• Performs other related duties as assigned.
  
  
  

• Bachelors Degree preferably in a health science or legal/regulatory studies
• 3 years of direct experience in Regulatory Affairs Clinical Affairs or Quality Assurance within the Medical Device Industry

Preferred:

• 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 required; some medical knowledge preferred.