[Hiring] Senior Regulatory Compliance Coordinator @Mount Sinai Health System

Role Description

A Senior 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.

• Management of 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 the reviewing committees and personnel.
• Assisting in budget development by identifying research non-billables.
• Coordinating start-up meetings for new protocols.

The Senior Regulatory Compliance Coordinator will act as a mentor to junior staff—providing oversight and training to multiple study teams who develop and submit documentation and information for Institutional Review Board (IRB) review and who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies. The position will report into the Assistant Director of Regulatory Compliance.

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.

Qualifications

• Experience in regulatory compliance and clinical trials.
• Strong communication and interpersonal skills.
• Ability to work collaboratively in a team environment.
• Experience mentoring or training junior staff.

Requirements

• Knowledge of regulatory processes and requirements for clinical trials.
• Experience with Institutional Review Board (IRB) submissions.
• Ability to manage multiple projects simultaneously.

Benefits

• Comprehensive health care solutions.
• Opportunities for professional growth and development.
• Supportive and inclusive work environment.