Senior Clinical Research Monitor (Remote) - Tisch Cancer Center
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
ā¢ 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.
ā¢ Conducts Exit Conference with Investigator and research team staff to review observations.
ā¢ 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.
ā¢ Assists in the development of education materials, quality improvement initiatives, root causes analyses, and corrective and preventative action planning.
ā¢ Generates audit reports analysis in accordance with the Mount Sinai School of Medicine's standard formats and timelines.
ā¢ Performs, where applicable, and at the request of the IRB and/ or Clinical Research Support Unit Leadership, audits of clinical trials.
ā¢ Assists with the development of Risk Assessment tools and templates in order to identify and correct compliance issues and/ or implement process improvement.
ā¢ Recommends changes in policies and procedures to ensure compliance with regulatory and federal guidelines.
ā¢ Trains, advises and mentors less senior staff.
ā¢ Other duties as assigned.
Qualifications
ā¢ Bachelor's Degree in a Science related field; Masters Degree preferred
ā¢ 7+ years of experience as a clinical research coordinator is required to include at least 5 years of progressive auditing/monitoring experience
ā¢ ACRP (Association of Clinical Research Professionals) Certification strongly preferred
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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
ā¢ 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.
ā¢ Conducts Exit Conference with Investigator and research team staff to review observations.
ā¢ 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.
ā¢ Assists in the development of education materials, quality improvement initiatives, root causes analyses, and corrective and preventative action planning.
ā¢ Generates audit reports analysis in accordance with the Mount Sinai School of Medicine's standard formats and timelines.
ā¢ Performs, where applicable, and at the request of the IRB and/ or Clinical Research Support Unit Leadership, audits of clinical trials.
ā¢ Assists with the development of Risk Assessment tools and templates in order to identify and correct compliance issues and/ or implement process improvement.
ā¢ Recommends changes in policies and procedures to ensure compliance with regulatory and federal guidelines.
ā¢ Trains, advises and mentors less senior staff.
ā¢ Other duties as assigned.
Qualifications
ā¢ Bachelor's Degree in a Science related field; Masters Degree preferred
ā¢ 7+ years of experience as a clinical research coordinator is required to include at least 5 years of progressive auditing/monitoring experience
ā¢ ACRP (Association of Clinical Research Professionals) Certification strongly preferred
Apply tot his job
Apply To this Job