Mount Sinai Hospital

Senior Clinical Research Monitor (Remote) - Tisch Cancer Center

Mount Sinai Hospital • $100K — $130K *
New York, NY 10128In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
More than 3 months ago
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in a Science related field; Master's Degree preferred
  • 7+ years of experience as a clinical research coordinator
  • At least 5 years of progressive auditing/monitoring experience
  • ACRP Certification strongly preferred

Responsibilities

  • Perform ongoing internal reviews of research projects for compliance with regulations and guidelines
  • Conduct Exit Conferences with Investigators and research staff to discuss findings
  • Assist study teams with regulatory agency inspections and external audits
  • Develop educational materials and quality improvement initiatives
  • Generate audit reports according to standard formats and timelines
  • Conduct audits of clinical trials as requested
  • Help create Risk Assessment tools to identify and resolve compliance issues
  • Recommend changes to policies and procedures for regulatory compliance
  • Mentor and train less senior staff

Benefits

  • Mentorship opportunities to develop supervisory skills
  • Exposure to regulatory agencies and inspections experience
  • Participate in quality improvement initiatives
  • Collaboration with the Principal Investigator and key stakeholders
  • Engagement in the development of educational materials and processes
Full Job Description
Job Description

The Senior Clinical Research Monitor is responsible for performing ongoing internal reviews of research projects where human subject research is involved to ensure Investigators are compliant with federal regulations and guidelines governing clinical research, good clinical practices and institutional policies and procedures. The Senior Clinical Research Monitor mentors and advises less senior staff.

Responsibilities

  • Performs ongoing internal reviews of regulatory and essential documents, standard operating procedures (SOP), subject case files, protocol compliance, data and safety monitoring, and pharmacy and/ or device documents (investigational product compliance)for IRB approved trials conducted by Tisch Cancer Institute.
  • Conducts Exit Conference with Investigator and research team staff to review observations.
  • Assist study teams in preparation for regulatory agency inspections and external audits. Participates in the conduct of agency inspections and external audits. Provides support to the Quality Assurance team, Principal Investigator, study team, and other key stakeholders before, during and after inspections and/ or audits.
  • Assists in the development of education materials, quality improvement initiatives, root causes analyses, and corrective and preventative action planning.
  • Generates audit reports analysis in accordance with the Mount Sinai School of Medicine's standard formats and timelines.
  • Performs, where applicable, and at the request of the IRB and/ or Clinical Research Support Unit Leadership, audits of clinical trials.
  • Assists with the development of Risk Assessment tools and templates in order to identify and correct compliance issues and/ or implement process improvement.
  • Recommends changes in policies and procedures to ensure compliance with regulatory and federal guidelines.
  • Trains, advises and mentors less senior staff.
  • Other duties as assigned.


Qualifications

  • Bachelor's Degree in a Science related field; Masters Degree preferred
  • 7+ years of experience as a clinical research coordinator is required to include at least 5 years of progressive auditing/monitoring experience
  • ACRP (Association of Clinical Research Professionals) Certification strongly preferred


About Mount Sinai Hospital

Mount Sinai Hospital is a hospital network based in New York City. It was founded in 1852 and is one of the oldest and largest teaching hospitals in the United States. The hospital has been ranked among the top hospitals in the country by U.S. News & World Report and is known for its excellence in patient care, research, and education. Mount Sinai Hospital is affiliated with the Icahn School of Medicine at Mount Sinai and has a staff of over 7,000 physicians, nurses, and other healthcare professionals.
Learn more about Mount Sinai Hospital
Size
42,000 employees
Industry
Healthcare
Founded
1997
* Ladders Estimates

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