Senior Clinical Research Associate

Overview

Werfen

Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories.  The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing.  Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality.  We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA.  Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA.  Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.

Position Summary:

Coordinates and supports trials and evaluations of diagnostic instruments and reagents at different hospital sites within US and Europe through all the phases of the product life: beta evaluations of new products (instruments and reagents), post-launch studies, extensions of product claims.

Responsibilities

Key Accountabilities

Essential Functions:

• In coordination with the Clinical Research Manager, defines and implements the plan for trials and evaluations, including participation in the design and administration/monitoring.
• Ensures compliance with protocol and overall clinical objectives at the trial or evaluation site. 
• Establishes relationships with potential clinical sites/accounts.
• Organizes the studies at the selected sites, including installation of instruments and applications, training of technical personnel at the selected sites, accurate storage and disposition of investigation product and study supplies, and, as needed, on-site support for the duration of the evaluation.
• Collects results and data analysis with the support of the Clinical Research Manager and performs on-site and preliminary data analysis as needed.
• Supports the preparation of reports, white papers and scientific publications.
• Responsible for the completeness and quality of the on-site files.
• Supports study protocols in Customer Simulation Laboratory.
• Other duties as assigned

Budget Managed (if applicable):

• N/A

Internal Networking/Key Relationships:

• To be determined based on department needs

Skills & Capabilities:

• Excellent interpersonal, verbal, and written communication skills
• Experience with MS Office and software used for data analysis in method evaluation

Qualifications

Minimum Knowledge & Experience Required for the Position:

• BS in Medical Technology with Clinical Research Associate (CRA) certification or equivalent
• Minimum of 5 years previous experience in a clinical laboratory, or in other diagnostic companies as a product support specialist/technical support specialist, or in product development
• At least 5 years clinical research experience in coordinating or monitoring IVD trials

International Mobility: Required:

• Yes

Travel Requirements: 

• Available to travel at least 30% of the time (domestic and international); flexibility is required to coordinate and manage on-site clinical activities

If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.

Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V.

We operate directly in over 30 countries, and in more than 100 territories through distributors.  Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.

www.werfen.com

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