Ground breaking science. Advancing medicine. Healing made personal.
The Senior Clinical Research Monitor 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. In this role, you will oversee study team members in accordance with the specific protocol documents and federal regulations.
Roles & Responsibilities:
- 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 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.
- Assists in the development of education materials.
- 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.
- Trains and mentors Clinical Research monitors.
- Other duties as assigned.
- Education: Bachelor's Degree in a Science related field; Master’s Degree preferred.
- Experience: 7+ years of experience as a clinical research coordinator required to include at least five years of progressive auditing/monitoring experience.
- Oncology experience required.
- ACRP certification is strongly preferred.
- Supervisory experience desired.
- Excellent organizational and communication skills required.
- SoCRA or ACRP certification strongly preferred.
The Mount Sinai Health System believes that diversity and inclusion is a driver for excellence. We share a common devotion to delivering exceptional patient care. Yet we’re as diverse as the city we call home- culturally, ethically, in outlook and lifestyle. When you join us, you become a part of Mount Sinai’s unrivaled record of achievement, education and advancement as we revolutionize healthcare delivery together.
We work hard to recruit and retain the best people, and to create a welcoming, nurturing work environment where you have the opportunity and support to develop professionally. We share the belief that all employees, regardless of job title or expertise, have an impact on quality patient care.
Explore more about this opportunity and how you can help us write a new chapter in our story!
Over 38,000 employees strong, the mission of the Mount Sinai Health System is to provide compassionate patient care with seamless coordination and to advance medicine through unrivaled education, research, and outreach in the many diverse communities we serve.
Formed in September 2013, The Mount Sinai Health System combines the excellence of the Icahn School of Medicine at Mount Sinai with seven premier hospitals, including Mount Sinai Beth Israel, Mount Sinai Brooklyn, The Mount Sinai Hospital, Mount Sinai Queens, Mount Sinai West (formerly Mount Sinai Roosevelt), Mount Sinai St. Luke’s, and New York Eye and Ear Infirmary of Mount Sinai.
The Mount Sinai Health System is an equal opportunity employer. We promote recognition and respect for individual and cultural differences, and we work to make our employees feel valued and appreciated, whatever their race, gender, background, or sexual orientation.