Medtronic Clinical Research Monitor(CRA) in Moscow, Russia

Clinical Research Monitor(CRA)

Location:

Moscow, Moscow, Russian Federation

Requisition #:

170007MM

Post Date:

Jun 09, 2017

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

For our Clinical Research department we are currently looking for a

Clinical Research Monitor

MAIN PURPOSE OF JOB:

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.

MAIN JOB DUTIES/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:

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

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

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

• Managing site assignments in collaboration with manager

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

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

• Overseeing action item tracking and resolution status

• Performing co-monitoring visits as needed

• Ensuring Monitoring Plan requirements are being met and escalates risks

• Attending Core/Study team meetings

BASIC JOB QUALIFICATION/EDUCATION:

• Bachelor’s Degree in life sciences, nursing or other health related Disciplines

• Two (2) years Clinical Research experience or Master’s degree and no experience required

DESIRED/PREFERRED QUALIFICATIONS:

• One (1) year of Clinical Research monitoring preferred

• Capable of clearly and effectively communicating verbally and in writing

• Excellent interpersonal skills

• Experience working in a team/matrix environment requiring strong working relationships

• Ability to handle and prioritize multiple therapeutic areas and projects simultaneously

• Ability to work in a fast paced environment

• Competencies and essential skills in the following: cross functional relationships, decision making, execution/results/process improvement, customer satisfaction

• Demonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands

• High attention to detail and accuracy

• Excellent problem solving skills

• Experience with word processing, spreadsheets, and databases applications (e.g., MS Word and Excel)

• Basic understanding of any applicable regulations (e.g., Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical research ethics,

• HIPAA and patient privacy laws, EU Directive, etc.)

• Business knowledge or experience with the medical / healthcare industry

• Class III medical device and/or phase II, III and IV pharmaceutical experience

• Experience of conducting clinical research activities in a regulated environment

• Proficient knowledge of medical terminology

• Regulations/standards training (FDA, ISO, GCP and other country specific training, such as for Canada, Asia, Latin American, etc. as applicable)

• Scientific/clinical knowledge needed to adequately monitor the trial (e.g. general therapeutic area education and training)

PHYSICAL REQUIREMENTS:

• The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

• While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers

• Ability to travel up to 80%

• Travel with colleagues and manager as requested.

• May require international travel