Careers that Change Lives
The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
PAIN THERAPIES offers solutions from early interventional procedures to implantable surgical technologies that treat chronic pain as well as pain from spinal fractures, cancer and severe spasticity.
A Day in the Life
The Clinical Research Specialist works under the supervision of the study manager to satisfy applicable clinical and regulatory requirements and Medtronic internal requirements for the design, initiation, management, monitoring and closing of clinical studies.
Responsibilities may include the following and other duties may be assigned.
Follow all work/quality procedures to ensure quality system compliance and high quality work.
Under the direction of the study manager, will assist with review and writing of clinical plans, study work instructions and guidelines, as well as performing activities and generating reports for one or more significant subparts of the study (e.g., monitoring, data management, adverse events, deaths, protocol deviations, legal agreements, study training, patient informed consents, clinical document management)
Ensure documentation meets regulatory requirements.
Assists in the development of the Clinical Investigational Plan, Clinical Management Plan, Data Management Plan, study training materials, and study reports in consultation with the study manager, clinical team, and investigators.
Assists with site identification, qualification, initiation, training, monitoring, and close out activities to ensure study compliance and subject protection.
Oversees, designs, plans and develops clinical evaluation research studies.
Prepares and authors protocols and patient record forms.
Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
Oversees and interpret results of clinical investigations in preparation for new drug device or consumer application.
Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations, and may prepare clinical trial budgets.
May be responsible for clinical supply operations, site and vendor selection.
Must Have: Minimum Requirements
Minimum of 2 years of experience supporting clinical research, or advanced degree with 0 years of experience supporting clinical research.
Nice to Have
Proficient knowledge of medical terminology
Ability to incorporate and adhere to good clinical practices and regulatory standards
High attention to detail and accuracy
Ability to identify and implement solutions in addressing study issues
Ability to cultivate relationships with customers and co-workers in a cross-functional environment
Capable of clearly and effectively communicating verbally and in writing
Ability to adapt to shifting priorities and competing demands
Ability to maintain composure in difficult circumstances
Ability to identify and overcome obstacles
Experience with Microsoft Word, Excel, PowerPoint; and familiarity with web-based applications
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 above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Day in the Life 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.
Ability to travel up to 30% of the time.