What are the responsibilities and job description for the Clinical Research Associate II position at Actalent?
Overview: Clinical Research Associate II
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.
Key Accountabilities:
• Ensures compliance with protocol and overall clinical objectives at the trial or evaluation site. Establishes and maintains 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, provide on-site support for domestic and international evaluations, and accurate storage and disposition of investigation product and study supplies.
• Collects results and data analysis with the support of others 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 as needed.
• Other duties as assigned
Skills & Capabilities:
• Excellent interpersonal, verbal, and written communication skills
• Experience with MS Office and software used for data analysis in method evaluation
• Ability to learn and understand complex scientific/clinical concepts
• Experience with Hemostasis or Blood Gas instrumentation is a plus
Min Knowledge & Experience Required for the Position:
• BS in Biology, Biochemistry or Chemistry or Medical Technology.
• Must have Clinical Research Associate (CRA) certification or equivalent
• At least 2 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 2 years clinical research experience in coordinating or monitoring IVD trials
• Excellent interpersonal, verbal, and written communication skills
• Experience with MS Office and software used for data analysis and statistics used in method evaluation and other analytical metrics
• Technical knowledge of automated clinical systems and assays
International Mobility: Required: yes
Travel Requirements:
• Available to travel at least 50% of the time (domestic and international)
• Flexibility is required to coordinate and manage on-site clinical activities
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
