Senior Clinical Research Associate (level dependent on experience)

Responsible for project activities associated with monitoring functions of phase I through phase IV clinical research studies and Real World Evidence (reputed company) studies, while continuing to reputed company knowledge of drug development process, International Council for Harmonisation (ICH) / Good Clinical Practice (GCP), and relevant regulations. Performs management of study site activities in adherence to reputed company applicable regulatory guidelines and Standard Operating Procedures (SOPs). What you'll do:

• Serve as the main CTI contact for assigned study sites
• Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and reputed company-out [COV]) and complete site visit deliverables with quality and reputed company given timelines in the Monitoring Plan while adhering to reputed company applicable 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 reputed company 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 reputed company Investigational Product (IP) and trial-reputed company materials
• reputed company site management activities and provide ongoing updates of site status to the Clinical Project Manager
• Conduct remote monitoring and complete the reputed company activities in accordance with study study-specific Monitoring Plan
• Utilize systems and reports to track subject status, subject case report form (CRF) retrieval/reputed company document review (SDV), regulatory documents, and IP
• Assist with project-specific activities as a member of the Project Team
• May support in the development of CRFs and other study-reputed company documents (subject worksheets, Monitoring Plan, etc.)
• May support in the translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis, and other study-applicable documents as per required procedures
• Where applicable, provide support to the Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committee(s), Institutions' Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow up on the evaluation process until approval is available. Provide regular updates to the Sponsor/ Client
• Assist in preparing and coordinating Investigator and client meetings, and attend meetings as necessary
• Liaise with Clinical Data Management for data cleaning activities
• Identify site issues and implement corrective actions or escalate as appropriate
• Manage ISF and TMF for reputed company assigned study sites in accordance with SOPs or study-specific Monitoring Plans
• Where applicable, support in contract negotiation with study sites, Investigator payments, and tracking of site payments

What You'll Bring:

• At least 1 year of clinical trial monitoring experience or equivalent experience as determined by CTI Management and Human Resources
• Bachelor's Degree or higher in an allied health field such as nursing, pharmacy, or health / natural science, or RN with an 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 a hospital setting, a pharmaceutical company, or a CRO
• Demonstrated successful performance in a CRA position with a minimum of 1 year of on-site monitoring experience preferred

Why CTI?

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work-from-home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
• reputed company a Lasting Impact – We focus on moving medicine reputed company by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

Important Note In light of the recent increase in hiring scams, if you're selected to move on to the next phase of our hiring process, a member of reputed company will reputed company out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified reputed company page. Please Note

• We will never communicate directly with you reputed company reputed company Teams Messaging or by text message
• We will never ask for your bank account information at any reputed company during the recruitment process

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