Clinical Research Associate jobs in West Haven, CT

Careers that Change Lives

 

In this exciting role as a Senior Clinical Research Specialist (CRS) in our Robotic Surgical Technologies Business Unit, you will have primary responsibility in the execution and oversight of global clinical studies. 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 overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.  Assumes project management responsibilities for selected studies and 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.

We're making that exciting future possible — and disrupting one of the biggest and fastest growing markets in healthcare — with a game-changing portfolio of robotic and data & analytics technologies, services, and solutions. 

 

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions. To learn more about Inclusion & Diversity at Medtronic Click Here

Ability to travel 30% (domestic and international)

A Day in the Life

·         Oversight of a clinical study from preparation, activation, enrollment, submission, maintenance, and study closure phases. 

·         Develop and design 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., FCRAs, BDM, Safety, EDC.

·         Trains study sites, ensures site compliance in regulatory requirements, maintains follow-up compliance, and represents Medtronic as a prime contact on the project.

·         Assists with the overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies, e.g., monitoring reports, device tracking and CAPA tracking systems.

·         Evaluates clinical and adverse event data for completeness during the conduct of the study and for completion of clinical study reports.

·         Ensures appropriate oversight of clinical study by 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.

 

Other Responsibilities: 

·         Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.

·         Minimum 3 years’ experience directly supporting clinical research or relevant experience in medical/scientific area.

·         Master’s degree will substitute for 1 year of experience. PhD or MD will substitute for 2 years of experience.

·         Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology.

·         Computer skills (MS Office products, word processing, spreadsheets, etc.).

·         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.

·         Presents professional manner and appearance

Responsibilities may include the following and other duties may be assigned.

• 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.
• People working within region/country may also have the responsibilities that include:
• Represents Medtronic from a clinical research respective within the country / region and also collects feedback from local customers and authorities.
• Builds and maitains optimal relationships and effective collaborations with various internal and external parties.
• Drives local evidence dissemination & awareness.

Must Have: Minimum Requirements

• Bachelors degree required
• Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience

Nice to Have

·         Degree in engineering, life sciences, or related medical/scientific field

·         3 years’ 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

About Medtronic


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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)