Clinical Research Spec
About The Position
This position will be a full-time S&SS CRS position supporting the CAS Site Management Team. In this exciting role as a Clinical Research Specialist, you will have primary focus responsibility in preparing sites for data collection, relationship building with research coordinators, regulatory report writing, and data cleaning. The CRS works under the direction of a Clinical Study Manager and assists with numerous tasks associated with the execution of a clinical trial. The Study & Scientific Solutions (S&SS) is a function within Medtronic Core Clinical Solutions (MC2). S&SS is an internal service provider to all of Medtronic and assigns resources to assist Business Units execute on clinical trials and scientific projects when they have an increase in workload. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. This position is remote to enhance our competitive edge and expand our cross-functional collaboration efforts. This role will require 10% of travel to enhance collaboration and ensure successful completion of projects.
Requirements
- 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.
- Candidates must possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Nice To Haves
- 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)
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.
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)
- Paid sick time (for temporary employees, as required under applicable state law)
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
