Associate Clinical Research Monitor (CRA)
Careers that Change Lives
As the Associate Clinical Research Monitor you would be responsible for the oversight of clinical research conducted at investigational sites to ensure compliance with study protocols, applicable regulatory standards, Ethics Committee/Institutional Review Board (IRB/EC) policies as well as procedures and business policies. This position works under supervision as needed, with a lot of flexibility for personal development. You would work closely with study management teams within Medtronic and site personnel for resolution of site issues towards successful clinical studies execution.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
- Training investigators and site personnel
- Performing monitoring activities of clinical trials at the site or remotely and ensuring all is conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP), and other applicable regulatory requirements
- Collaborating with clinical investigators, affiliated hospitals, and research institutions to initiate and expedite clinical studies on products that have investigational new drug or medical devices approval
- Reviewing adverse event cases with investigators, preparing study documents, and issuing reports
- Recommending qualified investigators for sites selection
- You may be assisting with design and monitoring planning of clinical evaluation projects
Must Have: Minimum Requirements
Nice to Have
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.
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. For Office Roles: 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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
- Bachelor or Master’s degree in life sciences, nursing or other health related disciplines
- Experience in Clinical Research related activities
- You have at least one (1) year of Clinical Research Monitoring (preferred)
- Fluent in English and Italian
- You are eager to learn, talented, dynamic, motivated, passioned & team-player
Nice to Have
- Clearly and effectively communicate verbally and in writing
- Good interpersonal skills and comfortable with working with others
- Proactivity, Ability to work in a fast paced and changing environment
- Ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands
- High attention to detail and accuracy
- Good problem-solving skills
- Work with Word, PowerPoint, Excel spreadsheets and databases applications
- Basic Understanding of any applicable regulations and standards (e.g., Training on Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical research ethics, EU Directive, etc.)
- Business knowledge or experience with the medical/healthcare industry, knowledge of medical terminology
Additional Information
- Posting Date: 21/09/2021
- Travel: Yes, 25-75 %, with working from home opportunities
What do we offer You for all your hard work?
- Day to day challenges, passionate and engaged teamwork
- An extraordinarily good and diverse work environment with colleagues from all over the world
- Working within multiple therapeutic areas
- Volunteering opportunities
- Attractive salary and benefits
- Room for new initiatives and ideas to do things better and smarter. We are always open to those, whether you are new or with us for years
- Generous number of leave days (as long as you promise to come back)
- Flexible working hours
- World class training and development possibilities
Company Values
- Patient centric – Our first and foremost priority is to contribute to human welfare
- Recognition of the personal worth of all employees – Providing an employment framework that allows personal satisfaction in work accomplished, security, advancement opportunity, and means to share in the company’s success
- Importance on Diversity and Inclusion
Company benefits
- Generous rewards and recognition scheme
- Large collection of resources for training and personal growth
- Clear career progression – importance on developing employees
- Pension scheme
Enthusiastic? Then this might be the position you were waiting for. Please let us know directly via the apply button!
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.
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. For Office Roles: 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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
