Medtronic Senior Clinical Research Monitor in Mansfield, Massachusetts02048

Senior Clinical Research Monitor

Location:

Mansfield, Massachusetts, United States

Requisition #:

17000BN9

Post Date:

2 days ago

POSITION DESCRIPTION:

The Senior 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 requirements. This position works under minimal supervision, working closely with study teams, site personnel, Medtronic field personnel and monitoring supervisor for resolution of site issues. The Senior Clinical Research Monitor may play a leadership role in overseeing monitoring activities and contributes as an experienced member of the clinical research team.

POSITION RESPONSIBILITIES:

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

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

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

 Identify site needs and propose solutions to facilitate the clinical trial process

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

 Provide input into the development and improvement of investigator and site management systems (e.g., CTMS)

 Assist in or conduct 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

 Propose solutions and collaborate with monitoring management and study team personnel towards securing Investigator compliance.

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 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

 Mentor and/or train junior personnel

 Adhere to all applicable Medtronic policies and procedures

 Attend internal department and team meeting as requested

In addition, the Senior Clinical Research Monitor may:

 Attend Investigator and/or Coordinator meetings

 Prepare meeting presentations and/or deliver training during meetings

(Investigator/Coordinator meetings, study/monitoring team meetings, etc.)

 Provide input into final study site selection

 Be involved in site management activities

 Assist sites/study teams with audit preparation

 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 Monitoring Plans and other study-related documents, or

portions thereof

o Creating 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 in accordance with current project

requirements

o Ensuring visits are forecasted appropriately to meet study

milestones and Monitoring Plan requirements

o Overseeing action item tracking and resolution status

o Performing co-monitoring visits as needed

o Ensuring Monitoring Plan requirements are being met and risks are

escalated

o Attending Core/Study team meetings

IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME

BASIC QUALIFICATIONS:

EDUCATION REQUIRED:

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 Bachelor’s Degree in life sciences, nursing or other health related disciplines

REQUIRED YEARS OF EXPERIENCE:

 4+ years clinical research experience with at least 2 years of clinical monitoring experience; or Master’s Degree with 2+ years clinical research experience and at least 2 years of clinical monitoring experience

DESIRED/PREFERRED QUALIFICATIONS

 Capable of clearly and effectively communicating verbally and in writing in English, in addition to respective local language if different than English

 Excellent interpersonal skills

 Ability to develop strong professional relationships

 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

 Experience working independently in a regional area with remote or minimal supervision

 Excellent problem solving skills

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

 Applied understanding of any applicable regulations and standards (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 to demonstrate understanding of technical, scientific and

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medical information

 Experience with Regulatory and Quality Assurance audits

 Experience in 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 JOB 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.

 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%, which may include both air and ground travel.

 Must have a valid driver's license and active vehicle insurance policy. In addition, driving record will be reviewed and will be considered as part of application.

 May require international travel

MEDTRONIC OVERVIEW:

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can 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.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.