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Dept- Tisch 015 REQ # 2564828
Job Title: Clinical Research Monitor
- The Senior Clinical Research Monitor, within the Tisch Cancer Institute, is responsible for performing ongoing 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 Tisch Cancer Institute is a vital component of the Icahn School of Medicine at Mount Sinai Hospital and plays a key role in the Mount Sinai Health System, which is one of the largest health care systems in the nation. We are a National Cancer Institute (NCI)-designated center and provide a multidisciplinary approach to cancer treatments and clinical breakthroughs that may one day put an end to cancer.
- Performs ongoing reviews of IRB approved trials.
- Examine the accuracy, completeness, and timeliness of research data which has been abstracted from source documentation and entered into the Electronic Data Capture system.
- Write detailed monitoring/audit reports for assigned studies.
- Develop documents and implement study-specific monitoring plans based on Institutional Data and Safety Monitoring Plan
- Conducts Exit Conference with Investigator and Clinical Research Coordinator to review findings.
- Generates audit reports analysis in accordance with the Mount Sinai School of Medicine's standard formats and timelines.
- Assists with the development of Risk Assessment tools in order to identify and correct compliance issues.
- Recommends changes in policies and procedures to ensure compliance with regulatory and federal guidelines.
- Other duties as assigned.
Bachelor's Degree in a Science related field; Master’s Degree preferred.
ACRP certification is strongly preferred.
Four+ years of experience as a clinical research coordinator required to include at least five
years of progressive auditing/monitoring experience;
Oncology experience required
Supervisory experience desired
Excellent organizational and communication skills required
SoCRA or ACRP certification strongly preferred.