Clinical Research Associate
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Description
We are seeking an experienced, high caliber Clinical Research Associate. Working with a moderate level of guidance and direction, assists in the planning and conduct of Legacy SJM Clinical studies. Ensure compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards, and Legacy SJM Standard Operating Procedures. Able to solve a range of straightforward problems and analyze possible solutions using standard procedures. Focus is on site management activities such as collection of essential documents, identifying and obtaining missing data, data corrections, reviewing and trending adverse events and protocol deviations. May contribute to developing study related materials and assist with writing reports. May also assist with the oversight of vendors and committees such as core labs and safety boards.
Each employee can make a difference and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
Contributions:
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Ensures both regulatory and clinical protocol compliance is maintained for all assigned clinical projects.
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This may include but is not limited to:
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Assists in the development of study related materials such as: patient brochures, patient recruitment material, and presentations
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Assists in writing sections of the protocol summary, annual report, and other study reports
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Assists in the development and review of informed consent document to ensure all required elements are included
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Assists with site nomination, qualification, and selection processes
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In consultation with the assigned field clinical and appropriate in-house personnel, coordinates the start-up and maintenance of the clinical study site
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Coordinates activities with study specific committees, vendor services, and core labs
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Reviews and analyzes data and documents for accuracy and completeness
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Creates and processes data queries
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Assists with preparation, follow-up, and resolution of findings from monitoring visits and audits
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Reviews and processes product complaints and adverse events as soon as they are reported
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Drafts Serious Adverse Event narratives
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Serves as a liaison to clinical study management, field clinical personnel and site personnel by responding to any protocol-related issues and escalating as appropriate
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Ensures the clinical study site adheres to the assigned protocol and all applicable regulatory standards
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Notify appropriate study management when concerns exit
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Communicates and collaborates with all levels of employees, customers, contractors, and vendors
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Applies general clinical research processes and regulatory knowledge to process improvement activities
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Trains internal and external clinical professionals to ensure compliance with established protocols
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Mentors less experienced clinical team members
Your experience(s), education and knowledge will further expand our marketplace success:
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A Bachelor degree from an accredited university or college
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Preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering, or a related academic field
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Minimum two years clinical research experience
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Must have demonstrated strong written and verbal communication, interpersonal, presentation, analytical, organizational skills, and the ability to interpret basic clinical data, to meet deadlines as well as the ability to communicate effectively with all levels of employees
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Familiarity with Microsoft word, Excel and Outlook programs and relevant clinical applications
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The ability to work independently when necessary
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The ability to exchange straightforward information, ask questions, and check for understanding
Your preferred qualifications and education:
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A general familiarity with clinical trials research processes
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Previous related experience in research within a clinical or corporate setting or relevant clinical experience in a clinical/hospital environment
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Certification as a Research Professional by Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP)
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Work habits include organization, coordination of many tasks, accuracy, and attention to detail