Clinical Research Monitor (CRA) Richmond Chicago NY\NJ\Eastern PA
Medtronic - United States

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Position Description

The Clinical Research Monitor is responsible for the oversight of clinical research conducted at investigational sites to ensure compliance with study protocols, applicable regulatory standards, IRB/EC policies and procedures and business policies. This position works under general supervision, working closely with study teams, site personnel, Medtronic field personnel and monitoring supervisor for resolution of site issues.

Position Responsibilities

Perform site monitoring visits in accordance with the study Monitoring Plan to ensure compliance with the Investigational Plan, Monitoring Plan, applicable regulatory, IRB/EC, and Medtronic standards, guidelines and policies

Communicate visit findings with site personnel and complete a written letter for distribution to the Principal Investigator and appropriate site personnel for follow-up

Prepare site visit reports and correspondence for all visits conducted in accordance with the study Monitoring Plan

Identify site needs, provide solutions to facilitate the clinical trial process

Act as a primary point of contact for study sites as requested

Assist in initial and ongoing site personnel training as required

Identification and escalation of protocol deviations, discrepancies in data, and non-compliance to study protocols, applicable regulations, Good Clinical Practices and Standard Operating Procedures

Collaborates with monitoring management and study team personnel towards securing Investigator compliance

Understand the study protocol and accompanying background information (e.g., Investigator Brochure, Report of Prior Investigations etc.)

Possess a working knowledge of disease state and investigational product

Possess understanding of regulatory requirements

Attend internal department and team meeting as requested

Adhere to all applicable Medtronic policies and procedures

In addition, the Clinical Research Monitor may:
Attend Investigator and/or Coordinator meetings

Provide input into final study site selection

Be involved in site management activities

Be assigned lead monitor responsibilities which include but are not limited to:

o Providing input on study protocol, CRFs and other study documents

o Authoring or assisting in the creation of Monitoring Plans, monitoring section of Data Management Plans, and source document worksheets

o Assisting in the creation of corrective and preventive action plans and trending reports

o Managing site assignments in collaboration with manager

o Facilitating communication and information flow between assigned project teams and assigned monitors on project

o Ensuring monitors are trained, current with project requirements and understand study milestones

o Overseeing action item tracking and resolution status

o Performing co-monitoring visits as needed

o Ensuring Monitoring Plan requirements are being met and escalates risks

o Attending Core/Study team meetings

Basic Qualifications

EDUCATION REQUIRED:
Bachelors Degree

YEARS OF EXPERIENCE

Two (2) years Clinical Research experience

Must already live in the region

Medtronic - 2 years ago - save job - block
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Medtronic, Inc. is engaged in medical technology. The Company functions in seven operating segments that manufacture and sell device-based...