Senior Clinical Research Specialist

Imricor Medical Systems Inc•Burnsville, MN

just now•$105,000 - $147,000•Onsite

About The Position

The Senior Clinical Research Specialist will conduct clinical research throughout all stages of a project, including design, implementation, and execution. This role will be responsible for one or multiple global clinical studies at all phases (feasibility, pivotal, post market). The Sr CRS will be responsible for collecting, analyzing, and reporting accurate trial data to support expanded market access. This position is responsible for complying with the Quality System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.

Requirements

BA/BS education in relevant discipline required.
5 years clinical experience in the medical device industry strongly preferred.
Highly skilled and proficient at clinical trial management/execution – garnered from education and/or experience on the job
Conduct complex work under minimal supervision and with wide latitude for independent judgment.
Experience with Microsoft Office: Word, Excel, PowerPoint.

Responsibilities

Prepares and authors clinical documents such as: protocols, patient informed consents, case report forms, clinical trial agreements, and/or investigator brochures/report of prior investigations as needed.
Develops and executes site training on protocol and data management requirements.
Communicates with Regulatory agencies (FDA, European Competent Authorities, etc) to develop and implement clinical trials to support our products.
Develops monitoring plans and monitors or oversees monitoring of clinical sites.
Oversees adverse event review committees and/or data review committees as necessary (develop and execute charters).
Identifies and communicates with CROs as necessary based on study needs.
Oversee and resolve 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.
Prepares and maintains clinical trial budgets for specific projects.
Authors clinical reports (interim and final) for both regulatory bodies and publications as necessary.
Communicates cross functionally with multiple stakeholders in the company – including regulatory, marketing, product development.
Develops and delivers presentations for upper management as necessary regarding project status and data results.