Clinical Research Specialist, ICT
About The Position
In this exciting role as a Clinical Research Specialist (CRS), you will be responsible for conducting clinical studies in compliance with applicable clinical and regulatory standards and in alignment with Medtronic business needs. You will monitor progress and results of clinical investigations in preparation for device application and/or publications. You will be responsible for managing and meeting the objectives of a clinical study. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We are working onsite a minimum of 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects.
Requirements
- Bachelor's degree and a minimum of 2 years of clinical research experience Or advanced degree with 0 years of experience
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
- Ability to appropriately apply different standards related to medical devices/clinical research (SOPs, GCP, ISO, ICH, FDA, MEDDEV, MDR, etc.) as needed
- Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications
Nice To Haves
- Degree in engineering, life sciences, or related medical/scientific field
- CCRA certification (Certified Clinical Research Association), SOCRA
- Clinical research/clinical trials experience at Medtronic or within a medical device industry
- Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials
- Experience with Oracle Clinical, Veeva Vault, Medidata
- Experience managing multiple clinical research sites with proven results in study execution
- Experience in clinical operations
- Experience developing clinical strategies and study design
- Experience working on a global study team
- Experience in Research and Development (R&D)
- Project/program management skills/experience
Responsibilities
- Collaborate and partner with a cross-functional team which includes study management, safety, stats, monitoring, our field team, and others
- Work closely with hospitals participating in our clinical research studies ensuring they have the support from start-up through closure
- Drive the collection of study materials throughout the lifecycle of a clinical study ensuring the regulatory documents are maintained, data is being entered into the EDC, and ensuring prompt responses from site personnel
- Oversee and manage 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
- Conduct registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential
- Oversee and interpret results of clinical investigations in preparation for new device or consumer application
- Serve as liaison between program management and planning, study team, and leadership
- May be responsible for clinical supply operations, site and vendor selection
- Build and maintain optimal relationships and effective collaborations with various internal and external parties
- Drive local evidence dissemination & awareness
- Collaborate closely with medical affairs, regulatory, marketing, and other functions to gather feedback on key design elements of the trial and communicate status updates
- Assess project issues and develop resolutions to meet productivity, quality, and client-satisfaction goals and objectives
- Develop, maintain, and continuously improve the project management process, guidelines, tools / templates, best practices, and overall implementation
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Principal
