Senior Clinical Research Specialist

Description

Supervisor’s Title: Clinical Research Manager
Exempt or Non-Exempt: Exempt

Location: Must be able to work at Burnsville Location 

Compensation: The expected salary for this Minnesota-based position is between $105,000-147,000. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s knowledge, skills, and or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, and Retirement Benefits).

Basic Function 

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.

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.

Requirements

Qualifications

· 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.

Working Conditions

· Light work, exerting up to 20 lbs. of force or less.

· 85% of time requires viewing and working at computer screen.

· Significant work pace & pressure due to deadlines.

· Travel 25%

The statements above reflect the principal function and most significant duties of the job as necessary for its evaluation in relation to other jobs in the organization and shall not be construed as a detailed description of all the work requirements that may be inherent in the job. Any functions that are non-Essential will be identified as such above. A request for Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.