Mount Sinai Careers
CLINICAL RESEARCH COORDINATOR I - Health Policy
Strength Through Diversity
Ground breaking science. Advancing medicine. Healing made personal.
Roles & Responsibilities:
The Clinical Research Coordinator 1 supports the departmental and field activities for the conduct of clinical research studies in compliance with applicable regulatory standards, IRB policies and procedures and internal requirements. He/she will work collaboratively with the clinical trial Coordinators, Project Managers, Quality Assurance Coordinators and others. He/she will report directly to the Clinical Trial Regulatory Manager.
- Under the supervision of the Clinical Trial Regulatory Manager and the Quality Monitoring personnel, will draft correspondence as needed to support monitoring related communications to clinical sites, including follow up to outstanding items from previous visits
- Provide logistical support for monitoring visits including scheduling and document preparation as needed
- Will request, receive and log in source documentation related to protocol defined data collection from clinical sites. Will maintain tracking tool to document source received and source monitored
- Assist in coordination of remote monitoring across all trials, including but not limited to remote monitoring initiatives, remote electronic medical record access and electronic data capture source upload and verification
- Under the supervision of the Clinical Trial Regulatory Manager will request, receive and log in source documentation of adverse events in compliance with clinical trial protocols and regulatory guidance and policies. Will ensure complete de-identification of all source documentation received from clinical trial sites
- Under the supervision of the Clinical Trial Regulatory Manager, will request additional adverse event source documentation from the clinical sites required for the Event Adjudication Committee (EAC) as deemed necessary by clinical review at the Data Coordinating Center
- Under the supervision of the Clinical Trial Regulatory Manager, will compile and create working documents of site source documents, medical records and adverse events to be sent to the EAC in advance of scheduled meetings. Will provide logistical support to coordinate scheduling of meetings, conference room and AV equipment for meetings, attend and record minutes from each EAC meeting
- Under the supervision of the Clinical Trial Regulatory Manager, will enter data into the electronic data capture system following each EAC Meeting
- Create and manage calendar of all recurring and ad hoc conference calls, meetings and events for the Clinical Trials Monitoring team
- Participate in regular teleconferences, staff meetings, etc.
- Bachelor’s Degree required
- Proficiency in MS Office software is highly desirable. One year clinical research experience preferred
- No direct contact with patients, but HIPAA Compliance training required.
Strength Through Diversity
The Mount Sinai Health System believes that diversity 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 medicine together.
We work hard to acquire and retain the best people, and to create a welcoming, nurturing work environment where you can develop professionally. We share the belief that all employees, regardless of job title or expertise, can make 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 hospital campuses, including Mount Sinai Beth Israel, Mount Sinai Beth Israel 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.