Clinical Research Associate (CRA)

About the Role

This position involves managing clinical study site monitoring activities across phases I-IV and Real World Evidence studies, while deepening understanding of drug development, regulatory standards including ICH/GCP, and applicable SOPs. The CRA will oversee study site operations ensuring adherence to all pertinent regulations and protocols.

Key Responsibilities

• Act as primary CTI liaison for designated study sites
• Execute site visits including pre-study, initiation, interim monitoring, and close-out visits, ensuring timely and quality completion in line with monitoring plans and regulatory compliance
• Support study initiation tasks such as feasibility assessments, pre-study activities, and site selection
• Gather, review, and maintain essential regulatory documentation
• Engage in all required general and study-specific trainings
• Participate actively in investigator, client, and project meetings
• Develop and implement strategies to aid subject enrollment at sites
• Manage investigational product storage, dispensation, and accountability
• Provide continual site management updates to the Clinical Project Manager
• Perform remote monitoring activities following study-specific monitoring plans
• Utilize tracking tools to monitor subject status, regulatory documents, and case report forms
• Contribute to project team efforts and study document development including CRFs and monitoring plans
• Assist in translating and customizing key study documents as needed
• Support regulatory submissions and follow-up with ethics committees and authorities, providing updates to sponsors or clients
• Help manage contracts, investigator payments, and site payment tracking
• Oversee Investigator Site File (ISF) and Trial Master File (TMF) management per SOPs and study plans
• Identify site-related issues, implement corrective actions, or escalate accordingly
• Collaborate with Clinical Data Management for data cleaning efforts
• Organize and attend investigator and client meetings

Required Qualifications and Experience

• Minimum of one year clinical trial monitoring experience or equivalent as assessed by CTI management
• Bachelor's degree or higher in allied health fields such as nursing, pharmacy, health/natural science, or RN with associate degree, or 3-year nursing diploma with two years clinical nursing experience, or equivalent
• Prior experience conducting clinical research in hospital, pharmaceutical, or CRO settings

About the Employer

CTI Clinical Trial and Consulting Services is a global clinical research organization focused on advancing therapies for chronically and critically ill patients. Operating from its headquarters in Greater Cincinnati, OH, CTI collaborates globally with pharmaceutical, biotech, and medical device companies to support drug development from concept through commercialization.

Employee Benefits and Culture

• Structured mentoring and leadership development programs to support career growth
• Tuition reimbursement and dedicated training resources
• Inclusive culture spanning over 60 countries with a strong work-life balance focus
• Competitive health benefits, generous vacation policies, hybrid remote work options, and paid parental leave
• Community engagement through the CTI Cares program

Important Hiring Notice

Due to rising recruitment fraud, CTI mandates that communications concerning next steps in hiring will come solely from an official @ctifacts.com email. Applicants must apply directly via the official company website or verified channels. CTI will never initiate contact through Microsoft Teams or text, nor request personal bank information during hiring.