Supporting role for the Clinical Research team, mainly related to trial conduct and site management activities in EMEA following good clinical practice and all applicable regulations. This position will work collaboratively with the external Contract Research Organization, external vendors, field Clinical Research Associates, additional study team members, customers, and other internal partners enabling patient access to advanced care of their vascular disease.
This is a remote role, but candidate must reside within Europe.
Responsibilities
- Support all aspects of site nomination, selection, confirmation, activation, execution, data collection, monitoring, and closure activities.
- Develop strong relationships with members of the Clinical Research Team ensuring appropriate sponsor oversight of clinical research centers and trial activities.
- Drive the organization of Essential Documents and upkeep of the Trial Master File(s).
- Partner with study team to develop and maintain all study documents necessary for trial execution.
- Support the review of patient informed consent forms and case report forms as necessary.
- Develop Study Newsletters in collaboration with Clinical Program Management and field team members.
- Support study invoicing process.
- Maintain compliance to all SOP, GCP, and regulatory processes.
- Create study-level reporting metrics to support Clinical Program Managers and other team members as assigned.
- Good technical knowledge of Inari products and procedures.
- Good clinical process acumen and ability to drive clinical functional excellence activities.
- Drive high quality data collection to support scientific communications, clinical research, and statistics evidence dissemination strategies.
- Support Clinical Trial registration at ct.gov as requested.
- Support Trial Master File review and audit activities.
- Other duties as assigned
Qualifications
- 3+ years of experience in clinical research or administration.
- Bachelor’s degree in life sciences.
- Proficient with electronic databases used for clinical trials.
- Experience with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).
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Healthy disdain for the status quo.
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Able to work independently.
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Ability to thrive in a fast-paced and dynamic early-stage company work environment.
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Medical device trials experience preferred.
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Detail oriented with ability to deliver high quality output consistently and on time.
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Ability to thrive in times of change while adhering to cultural focus on People and Patients.
Inari Medical, Inc. advises applicants that employment is subject to completion of a successful background check.