Note: The job is a remote job and is open to candidates in USA. Medtronic is a global healthcare technology company developing medical technologies to improve patient health. The Clinical Research Specialist supports the CAS Site Management Team by preparing clinical research sites for data collection, building relationships with research coordinators, writing regulatory reports, cleaning data, and assisting with clinical trial execution.
Responsibilities
- 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
- Represents Medtronic from a clinical research respective within the country / region and also 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
Skills
- Bachelor's degree plus 2+ years of clinical site management 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
- Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment
- Bachelor's degree in degree in engineering, life sciences, or related medical/scientific field
- Previous Medtronic experience
- Clinical experience
- Site Management experience (site or sponsor)
- Knowledge of/experience with CTMS/EDC/TMF
- Experience with Good Clinical Practice (GCP)
Benefits
- Remote work arrangement
- This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
- For regular employees who work 20+ hours per week: Health, Dental and vision insurance
- For regular employees who work 20+ hours per week: Health Savings Account
- For regular employees who work 20+ hours per week: Healthcare Flexible Spending Account
- For regular employees who work 20+ hours per week: Life insurance
- For regular employees who work 20+ hours per week: Long-term disability leave
- For regular employees who work 20+ hours per week: Dependent daycare spending account
- For regular employees who work 20+ hours per week: Tuition assistance/reimbursement
- For regular employees who work 20+ hours per week: Simple Steps (global well-being program)
- For all regular employees: Incentive plans
- For all regular employees: 401(k) plan plus employer contribution and match
- For all regular employees: Short-term disability
- For all regular employees: Paid time off
- For all regular employees: Paid holidays
- For all regular employees: Employee Stock Purchase Plan
- For all regular employees: Employee Assistance Program
- For all regular employees: Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- For Vice Presidents and above, or subject to IRS earning minimums: Capital Accumulation Plan
- Temporary employees are eligible for paid sick time, as required under applicable state law
- Temporary employees are eligible for the Employee Stock Purchase Plan
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