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CLINICAL TRIALS MONITORING ASSOCIATE

Mount Sinai Health System


Location:
New York, New York 10029
Date:
10/24/2017
2017-10-242017-11-23
Categories:
  • Clinical Operations
Mount Sinai Health System
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Job Details

Do you have what it takes to wear the badge?

 Mount Sinai Health System's multidisciplinary clinical research teams are pioneering innovative new approaches in health care across a variety of fields. Working alongside leading physicians and within internationally acclaimed medical institutes, centers, and laboratories, our scientists continue to shape the future of clinical care and improve outcomes for patients of all ages.

 Are you ready to discover the world of limitless possibilities that comes with wearing the badge? Explore more about this opportunity and how you can help us write a new chapter in our story of unrivaled patient care!

 

What You'll Do:

 The Clinical Trials Monitoring Associate 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.

 

Duties and Responsibilities:

 *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.

 *Will request and follow to completion Action Items resulting from on-site monitoring visits.  Will document completion of Action Items.

 *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.

 *As experience is gained in the role, will train under the Clinical Trial Regulatory Manager and the Quality Monitoring personnel in clinical trials monitoring.

 *Under the supervision of the Clinical Trial Regulatory Manager and the Quality Monitoring personnel, will assist in source document verification as needed. 

 *Under the supervision of the Clinical Trial Regulatory Manager and the Quality Monitoring personnel, will assist in on-site monitoring of clinical trials data as needed.

*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.

 *Will review data completeness in the Electronic Data Capture System to verify that clinical site reimbursements are ready for payment.

*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.

 

What You'll Bring:

 Candidate must have strong interpersonal communication skills, both written and verbal. Attention to detail and strong organizational skills are required

Ability to multi-task and thrive in a dynamic fast-paced environment.

Candidate must be able to work independently within the scope of a team environment.

Experience working in an academic environment and at least one year of clinical research experience preferred.

MPH preferred.

Proficiency in MS Office software is highly desirable.

One year research experience preferred.

No direct contact with patients, but HIPAA Compliance training required.

 Do you share our dedication to extraordinary service and have what it takes to wear the badge? Apply now!

 

Who We Are:

Over 35,000 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 committed to the tenets of diversity and workforce that are strengthened by the inclusion of and respect for our differences. We offer our employees a highly competitive compensation and benefits package, a 403(b) retirement plan, and much more.

 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.

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