Medtronic Clinical Research Specialist North Haven, Connecticut Apply Now
At Medtronic, you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
In this exciting role as a Clinical Research Specialist (CRS) in our Robotic Surgical Technologies Business Unit, you will have primary responsibility in the execution and oversight of global clinical investigational sites. An individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. Most of the time is spent delivering and executing the projects, while adhering to policies and using specialized knowledge and skills normally acquired through advanced education and experience. Assumes project management responsibilities for site management activities as needed.
Surgical Robotics employees believe that every patient around the world deserves access to quality care and improved outcomes. Driven by our Mission, we believe that surgical robotics can add value to the healthcare ecosystem, lessen variability, and help more people around the world get better, faster.
Location: Mounds View, MN / Boston, MA / Lafayette, CO / North Haven, CT. Team could consider a candidate to work remotely from the U.S., but will have a strong preference for local/on-site talent.
Travel: 30% (domestic and international)
Responsibilities may include the following and other duties may be assigned:
- Oversight of assigned activities for a clinical study from preparation, activation, enrollment, submission, maintenance, and study closure phases.
- Prepares required clinical documents in consultation with the cross-functional project team, investigators, and the clinical team.
- Completes project tasks and provides site management along with ensuring successful interface with key functional groups, i.e., Start-up specialists, Data Management, Safety, Monitoring, etc.
- Trains study site personnel, ensures site compliance adherence to the study Clinical Investigational Plan and regulatory requirements, maintains follow-up compliance, and represents Medtronic as a primary contact for assigned sites.
- Assists with the overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies.
- Evaluates clinical and adverse event data for completeness during the conduct of the study and for completion of clinical study reports.
- Ensures appropriate execution of the clinical study with internal and external resources including, but not limited to monitoring staff, CROs, and core laboratories.
- Ensures quality by maintaining compliance, reviewing device complaints, reviewing audit reports, and implementing corrective actions.
- Regularly communicates study status to management.
- 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 interprets 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.
- Represents Medtronic from a clinical research perspective within the country/region and collects feedback from local customers and authorities.
- Builds and maintains optimal relationships and effective collaborations with various internal and external parties.
- Drives local evidence dissemination & awareness.
Must Have (Minimum Requirements):
- Bachelor's degree with 2+ years of clinical research experience
OR
- An advanced degree with 0 years of clinical research experience
Nice to Have (Preferred Qualifications):
- Degree in engineering, life sciences, or related medical/scientific field
- 3+ years’ of experience managing clinical trials within Medtronic or medical device industry
- Experience conducting an IDE or pre-market study team
- Experience in Surgical therapies/product
- Experience managing multiple clinical research sites with proven results in study execution
- Experience in managing clinical trial sites
- Basic understanding of clinical monitoring and auditing
- Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials, such as CFR 812, 50, 54, and ISO14155:2020
- Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology.
- High attention to detail and accuracy.
- Ability to manage multiple tasks.
- Good prioritization and organizational skills.
- Excellent problem-solving skills
- Positive outlook.
- Flexible and dependable.
- Works effectively on cross-functional teams.
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 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.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Salary ranges for U.S (excl. PR) locations (USD): $80,000.00 - $120,000.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location.
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves.
Learn more about our business, mission, and our commitment to diversity here.
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