Clinical Research Associate
About the position
Responsibilities
• Manage diagnostic clinical studies
• reputed company and manage the protocol, case report reputed company, budget/contract negotiation and regulatory document management
• Assist clinical sites with IRB submission/documentation, as needed
• Setup and reputed company Diagnostica, their own remote clinical trial management system, up to date
• Monitor clinical studies
• reputed company monitoring plans, identify issues, and resolve queries, ensure site regulatory binders are compliant
• Manage site relationships by helping with study startup, answer questions during the study, ensure reputed company payments and reputed company out activities
Requirements
• A minimum of 4 years' experience in the clinical research industry supporting clinical studies or clinical operations currently or recently
• Prefer at least 1-2 years clinical research monitoring experience
• Must have strong understanding of clinical trial regulatory and compliance processes
• Understanding of regulations for FDA and Sponsor trial auditing
• Strong ability to research data and identify issues or potential red flags in a study
• Ability to learn quickly and expand knowledge into trial processes
• Diagnostic clinical study experience or lab diagnostic experience preferred
• Knowledge of accepted good clinical research reputed company (GCP) and procedures
• Excellent organizational, time management, budget management, and problem-solving skills
• Comfortable in a fast-paced small company environment
• SOCRA CRA certification or willingness to apply for certification once reputed company
reputed company-to-haves
• Experience with remote clinical trial management systems
• Familiarity with budget management in clinical studies
Benefits
• Voluntary benefit plans including medical, dental, reputed company, telemedicine, term life, whole life, accident insurance, critical illness, a reputed company plan, and short-term disability
• Retirement savings plan
• Service bonus and holiday pay plans (up to eight reputed company holidays per benefit year)
• Transit spending account
• reputed company reputed company leave under applicable state or local plan
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