Clinical Research Associate II

Overview

Clinical Research Associate II - CRA II role at CTI Clinical Trial and Consulting Services. CTI is a global, privately held, full-service clinical contract research organization (CRO) focused on advancing treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms.

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What You'll Do

• Serve as main CTI contact for assigned study sites
• Conduct site visits (pre-study PSV, site initiation SIV, interim monitoring IMV, and close-out COV) and complete site visit deliverables with quality and within timelines in Monitoring Plan, adhering to regulatory requirements, SOPs, and ICH GCP
• Assist with study start-up activities, including feasibility, pre-study activities and site selection
• Collect, review and track essential/regulatory documents
• Participate in and complete all general and study-specific training as required
• Participate in investigator, client and project team meetings
• Create and implement subject enrollment strategies for assigned study sites
• Ensure proper storage, dispensation and accountability of Investigational Product (IP) and trial-related materials
• Perform site management activities and provide ongoing updates of site status to the Clinical Project Manager
• Conduct remote monitoring and complete related activities per the Monitoring Plan
• Utilize systems and reports to track subject status, CRF retrieval/SDV, regulatory documents, and IP
• Assist with project-specific activities as a member of the Project Team
• May support in development of CRFs and other study documents (subject worksheets, Monitoring Plan, etc.)
• May support translation and review of Patient Information Sheet, Informed Consent, protocol synopsis and other study documents as required
• Support Regulatory Affairs Start-Up activities in preparation or revision of documentation for ethics committees and regulatory authorities, providing updates to Sponsor/Client
• Support contract negotiations with study sites, Investigator payments and tracking of site payments
• Manage ISF and TMF for assigned sites in accordance with SOPs or study-specific Monitoring Plans
• Identify site issues and implement corrective actions or escalate as appropriate
• Liaise with Clinical Data Management for data cleaning activities
• Assist in preparing and coordinating Investigator and client meetings

What You Bring

• At least 2 years of clinical trial monitoring experience or equivalent experience as determined by CTI Management and Human Resources
• Fluent in English
• Bachelor's Degree or higher in allied health field such as nursing, pharmacy, or health/natural science, or RN with Associate's Degree, or 3-year Nursing Diploma with at least 2 years clinical nursing experience, or equivalent experience as determined by CTI Management and Human Resources
• Previous experience in conducting clinical research studies in hospital settings, pharmaceutical company or CRO
• Fully eligible to work in Argentina - CTI does not provide VISA Sponsorship

Why CTI?

• Advance Your Career – Structured mentoring, leadership development, and dedicated training to support your goals; ongoing education encouraged.
• Join an Award-Winning Team – Global team across 60 countries with a culture that prioritizes people; hybrid work opportunities; CTI Cares program for community involvement.
• Make a Lasting Impact – Contribute to developing life-changing treatments for patients with chronic and critical illnesses.

Important Note

In light of recent hiring scams, if you're selected to move onto the next phase, a member of our team will reach out from an email address to guide you through the interview process. Please apply only on our website ) or from our verified LinkedIn page.

EEO and Security

• We will never communicate via Microsoft Teams or text message for recruitment purposes
• We will never ask for your bank account information during recruitment

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Research, Analyst, and Information Technology

Industries

• Research Services

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