Clinical Research Associate II

CTI Clinical Trial and Consulting Services; Brussel; Hybride; EUR 60 000 - 85 000; Plein temps

Avantages offerts par ce poste

Hybrid work from home opportunities

Résumé du poste

CTI Clinical Trial and Consulting Services is seeking an experienced Clinical Research Associate to oversee monitoring activities at assigned study sites. The role includes site visits, regulatory document handling, and collaboration with sponsors and project teams to ensure quality and timelines.

You will contribute to study start-up, patient enrollment strategies, and IP accountability while maintaining regulatory compliance across trials. Hybrid work options may be available.

Qualifications

• Minimum 3 years of clinical trial monitoring experience.
• Fluent in English.
• Bachelor's degree or higher in allied health, life sciences, or nursing.
• Experience in conducting clinical research studies in hospital settings, pharmaceutical companies, or CRA roles.

Responsabilités

• Serve as main CTI contact for assigned study sites.
• Conduct site visits (PSV, SIV, IMV, COV) and complete site visit deliverables with quality within Monitoring Plan timelines.
• Assist with or oversee study start-up activities, including feasibility and site selection.
• Collect, review and track essential/regulatory documents.
• Participate in general and study-specific training as required.
• Participate in investigator, client and project team meetings; may include presentations.
• Create and implement subject enrollment strategies for assigned study sites.
• Ensure proper storage, dispensation and accountability of Investigational Product and trial-related materials.
• Perform site management activities and provide updates of site status to Clinical Project Manager.

Connaissances

Clinical trial monitoring

Regulatory understanding

Formation

Bachelor's degree or higher in life sciences

Description du poste

• 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 given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP
• Assist with or oversee 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; may include presentations
• 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 Clinical Project Manager
• Conduct remote monitoring and complete related activities in accordance with 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 member of Project Team Participate in the development of CRFs and other study related documents (subject worksheets, Monitoring Plan, etc.)
• Perform 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 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 the evaluation process until approval is available
• Provide regular updates to Sponsor/ Client Where applicable, support or oversee contract negotiation with study sites, Investigator payments and tracking of site payments
• Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans Identify and anticipate site issues and implement corrective and preventive actions or elevate as appropriate
• Liaise with Clinical Data Management for data cleaning activities
• Serve as mentor / trainer for CRAs; may include conducting training/assessment visits
• Function in the role of Lead CRA for assigned project(s)
• Identify and propose process improvements
• Provide therapeutic area expertise to team members

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 given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP
• Assist with or oversee 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; may include presentations
• 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 Clinical Project Manager
• Conduct remote monitoring and complete related activities in accordance with 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 member of Project Team Participate in the development of CRFs and other study related documents (subject worksheets, Monitoring Plan, etc.)
• Perform 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 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 the evaluation process until approval is available
• Provide regular updates to Sponsor/ Client Where applicable, support or oversee contract negotiation with study sites, Investigator payments and tracking of site payments
• Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans Identify and anticipate site issues and implement corrective and preventive actions or elevate as appropriate
• Liaise with Clinical Data Management for data cleaning activities
• Serve as mentor / trainer for CRAs; may include conducting training/assessment visits
• Function in the role of Lead CRA for assigned project(s)
• Identify and propose process improvements
• Provide therapeutic area expertise to team members

What You’ll Bring

• At least 3 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 setting, pharmaceutical company or CRA

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of 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. For more information, visit www.ctifacts.com

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.
• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.