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Mount Sinai Health System · 3 months ago

Senior Regulatory Compliance Coordinator - Tisch Cancer Institute

New York, NY

Full-time

Onsite

Senior Level

$72K/yr - $109K/yr

5+ years exp

Mount Sinai Health System is a leading academic medical institution, and they are seeking a Senior Regulatory Compliance Coordinator to manage cancer clinical trials within the Tisch Cancer Institute. The role involves overseeing the regulatory aspects of clinical studies, mentoring junior staff, and ensuring compliance with relevant regulations throughout the trial lifecycle.

Health CareHospitalMedical

Responsibilities

Assist multi-disciplinary group of hematology/oncology Principal Investigators and researchers with development of investigator-initiated clinical trial protocols

Develops and/or revises regulatory standard operating policies and procedures

Submits protocol applications for IRB review in a timely manner; tracks new protocols through the internal study start-up committee system to approval and activation, including responding to committees’ inquiries for clarification

Gathers clinical and safety data needed to prepare and process applications for IRB annual renewal review and approval

Collaborates with the Principal Investigator (PI) in completion of required regulatory documents including, but not limited to: Conflict of Interest forms, delegation of authority logs, legal agreements, investigational pharmacy forms, serious adverse event forms, etc

Collaborates with the Clinical Trials Manager in developing and ensuring clinical trial regulatory compliance

Coordinates communication with investigators and members of the research team to aid in study development and oversight throughout the life-cycle of clinical trial

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

Submits Investigational New Drug (IND) Applications and obtains approval from the Food and Drug Administration (FDA) for investigator-initiated clinical trials

Acts as primary contact for all FDA communication, including submission of serious adverse events, amendments, annual reports, and other submissions as required

Collaborates with the Financial Manager on the development of the study budget (as needed); identifies billable versus research non-billable procedures

Updates and maintains records of clinical trial status on clinicaltrials.gov website as mandated by FDA and National Institutes of Health (NIH)

Analyzes moderate to complex clinical research data related to oncology, immunology, microbiology, etc; Assists in interpreting clinical research data used in scientific publication

Coordinates research team communication, including: notification of clinical trial activation, enrollment closures, protocol amendments, and final study closures

Distributes regulatory documents throughout the life-cycle of clinical trial

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 and clinical data applied to the conduct of clinical trials

Acts as liaison between research team and sponsor for important clinical trial notices, updates, and monitoring visits

Mentors and trains less experienced research staff including Clinical Research Coordinators and Data Analysts

Participates in development of SOPs and ensures compliance within disease teams

Assists development of CCTO training activities

Provides mentorship and training to junior regulatory compliance coordinators

Performs other related duties as assigned

Qualification

Regulatory AffairsClinical Trials ManagementOncology ExperienceClinical PracticeData ManagementAnalytical SkillsMicrosoft OfficeCommunication SkillsOrganizational SkillsTeamworkMentorshipAttention to DetailProblem Solving

Required

Bachelors Degree (Masters preferred) ideally in science or health care policy

A minimum of 5 years of research experience in Regulatory Affairs, Clinical Affairs or Quality Assurance with knowledge of Phase I-IV clinical studies and data management aspects of clinical research

Preferred

Working knowledge of Good Clinical Practice guidelines and Code of Federal regulations

Oncology experience required; some medical knowledge preferred

Certification Preferred in one of the following: SoCRA, ACRP, or RAPS

Excellent written and oral communication skills

Ability to foster smooth communications and teamwork among clinical research faculty, fellows and staff as well as external sites and organizations (sponsors and contract research organizations)

Analytical skills for problem solving; attention to detail and accuracy

Demonstrate strong organizational skills; ability to manage multiple tasks & priorities

Solid experience in using MC Office programs and software including Word, Excel, PowerPoint, and Outlook