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Senior Regulatory Compliance Coordinator (Remote) - Tisch Cancer Center

Role overview

Qualifications

  • Experience managing cancer clinical trials
  • Knowledge of regulatory submission processes
  • Strong communication skills
  • Ability to mentor and train junior staff

Responsibilities

  • Manage clinical studies through the regulatory submission process
  • Ensure regulatory integrity from trial approval to closure
  • Develop new clinical trials and act as the main contact in protocol development
  • Coordinate start-up meetings for new protocols

About the company

Mount Sinai Morningside logo

Mount Sinai Morningside

At Mount Sinai Morningside, we offer exceptional clinical care and research within the comfort of a neighborhood hospital known for compassion and sensitivity. We are the leading health care provider for West Harlem and Morningside Heights and offer a level 2 trauma center. We have a proud tradition of medical firsts, particularly in the areas of cardiology and cardiac surgery. We also work hard to meet the varied needs of all residents of our community, including those who face multiple social and economic challenges. In addition, we work hard to lead the way in quality and safety, and to provide you with complete and accurate reporting on these issues.

Company details

Company size1001 - 5000

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Job 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.   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 Senior Regulatory Compliance Coordinator will act as a mentor to junior staffβ€” 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 Senior Regulatory Compliance Coordinator is a resource for Investigators and Research Teams 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.

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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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