Mount Sinai Medical Center New York, NY
Strength ThroughDiversity

Ground breaking science.Advancing medicine. Healing made personal.

Roles &Responsibilities:

The Clinical Research Coordinator 1 supports thedepartmental and field activities for the conduct of clinical research studiesin compliance with applicable regulatory standards, IRB policies and proceduresand internal requirements. He/she will work collaboratively with the clinicaltrial Coordinators, Project Managers, Quality Assurance Coordinators andothers. He/she will report directly to the Clinical Trial Regulatory Manager.

* Under the supervision of the Clinical TrialRegulatory Manager and the Quality Monitoring personnel, will draftcorrespondence as needed to support monitoring related communications toclinical sites, including follow up to outstanding items from previous visits

* Provide logistical support for monitoring visitsincluding scheduling and document preparation as needed

* Will request, receive and log in sourcedocumentation 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 monitoringacross all trials, including but not limited to remote monitoring initiatives,remote electronic medical record access and electronic data capture sourceupload and verification

* Under the supervision of the Clinical TrialRegulatory Manager will request, receive and log in source documentation ofadverse events in compliance with clinical trial protocols and regulatoryguidance and policies. Will ensure complete de-identification of all sourcedocumentation received from clinical trial sites

* Under the supervision of the Clinical TrialRegulatory Manager, will request additional adverse event source documentationfrom the clinical sites required for the Event Adjudication Committee (EAC) asdeemed necessary by clinical review at the Data Coordinating Center

* Under the supervision of the Clinical TrialRegulatory Manager, will compile and create working documents of site sourcedocuments, medical records and adverse events to be sent to the EAC in advanceof scheduled meetings. Will provide logistical support to coordinate schedulingof meetings, conference room and AV equipment for meetings, attend and recordminutes from each EAC meeting

* Under the supervision of the Clinical TrialRegulatory Manager, will enter data into the electronic data capture systemfollowing each EAC Meeting

* Create and manage calendar of all recurring andad hoc conference calls, meetings and events for the Clinical Trials Monitoringteam

* Participate in regular teleconferences, staffmeetings, etc.


* Bachelor's Degree required

* Proficiency in MS Office software is highlydesirable. One year clinical research experience preferred

* No direct contact with patients, but HIPAACompliance training required.

Strength ThroughDiversity

The Mount Sinai HealthSystem believes that diversity is a driver for excellence. We share a commondevotion to delivering exceptional patient care. Yet we're as diverse as thecity we call home- culturally, ethically, in outlook and lifestyle. When youjoin 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 acquireand retain the best people, and to create a welcoming, nurturing workenvironment where you can develop professionally. We share the belief that allemployees, regardless of job title or expertise, can make an impact on qualitypatient care.

Explore more about thisopportunity and how you can help us write a new chapter in our story!

Who We Are

Over 38,000 employeesstrong, the mission of the Mount Sinai Health System is to providecompassionate patient care with seamless coordination and to advance medicinethrough unrivaled education, research, and outreach in the many diversecommunities we serve.

Formed in September2013, The Mount Sinai Health System combines the excellence of the Icahn Schoolof Medicine at Mount Sinai with seven premier hospital campuses, includingMount Sinai Beth Israel, Mount Sinai Beth Israel Brooklyn, The Mount SinaiHospital, Mount Sinai Queens, Mount Sinai West (formerly Mount SinaiRoosevelt), Mount Sinai St. Luke's, and New York Eye and Ear Infirmary of MountSinai.

The Mount Sinai HealthSystem is an equal opportunity employer. We promote recognition and respect forindividual and cultural differences, and we work to make our employees feelvalued and appreciated, whatever their race, gender, background, or sexualorientation.