[Remote] Senior Clinical Research Associate (level dependent on experience)

Note: The job is a remote job and is open to candidates in USA. CTI Clinical Trial and Consulting Services is focused on advancing medicine through clinical research. The Senior Clinical Research Associate will manage project activities associated with monitoring clinical research studies, ensuring adherence to regulatory guidelines and Standard Operating Procedures while serving as the main contact for assigned study sites.

Responsibilities

• Serve as the 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 given timelines in the Monitoring Plan while adhering to all 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 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 all 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 the related activities in accordance with study study-specific Monitoring Plan
• Utilize systems and reports to track subject status, subject case report form (CRF) retrieval/source 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-related 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 all 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

Skills

• 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

Benefits

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow.
• Ongoing education and training through tuition reimbursement and a dedicated training department.
• Generous health benefits and vacation packages.
• Hybrid work-from-home opportunities.
• Paid parental leave.
• CTI Cares program.

Company Overview

• CTI is a full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services. It was founded in 1999, and is headquartered in Covington, Kentucky, USA, with a workforce of 1001-5000 employees. Its website is http://ctifacts.com.

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