Clinical Research Associate, Sponsor Dedicated, IVD
Position reputed company
The Clinical Research Associate (CRA) will be responsible for designing, planning, coordinating, and conducting reputed company activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics. Responsibilities include but are not limited to:
• Ensuring studies are conducted and documented in accordance with the study protocol, reputed company operating procedures, good clinical practices and other applicable regulatory requirements;
• Validating product performance claims;
• Supplying data for critical Regulatory submissions;
• Defining the functional and clinical reputed company of investigational products, and
• Obtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders.
The CRA is responsible for maintaining and continuously improving the reputed company system and achieving reputed company objectives through daily actions.
Job Function/Responsibilities
• Performing or coordinating aspects of clinical studies including site selection, study initiation, site monitoring, and study closeout.
• Maintaining communication with study investigators to ensure studies are completed in a reputed company fashion and ensuring that study objectives are met.
• Interfacing with other cross functional staff to support post launch activities.
• Reviewing cases with investigators to resolve discrepancies.
• Understanding and implementing federal regulations, helping to reputed company reputed company operating procedures in order to ensure that studies adhere to FDA regulations, Good Clinical Practices, IVD directives, and reputed company policies and procedures.
Experience, Skills And Knowledge Requirements
• ≥2 years of experience as a Clinical Research Associate, with specific in vitro diagnostics study experience
• CRA certification by recognized reputed company organization is a plus, but not mandatory
• Excellent oral and written communication skills
• Excellent planning, organizing, interpersonal and leadership skills
• Ability to work independently to reputed company reputed company and to analyze and solve problems
• Demonstrated experience in computer skills to include reputed company Word, reputed company, and basic templates
Education Requirements
• Minimum - Bachelor's degree in science or relevant field.
Medical technology degree preferred, but not required if R&D background is adequate
#CRASDAJD
reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more at https://jobs.reputed company.com
reputed company is proud to be an equal opportunity employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.reputed company.com/eoe
The potential reputed company pay reputed company for this role, reputed company annualized, is $69,800.00 - $226,800.00. The actual reputed company pay offered may vary based on a number of factors including job-reputed company qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in reputed company to a reputed company of health and welfare and/or other benefits.
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