Clinical Research Associate II

Ctifacts; Belgique; Hybride; EUR 42 000 - 62 000; Plein temps

Avantages offerts par ce poste

Hybrid work from home opportunities

Career development programs

Global exposure

Résumé du poste

CTI Clinical Trial and Consulting Services is seeking a seasoned clinical trial monitor to lead monitoring activities across assigned sites. You will ensure regulatory compliance, manage source data verification, and collaborate with cross-functional teams to drive trial quality and timelines.

The role includes site visits (PSV, SIV, IMV, COV), start-up support, and ongoing mentoring for CRAs within a global CRO framework. Hybrid work options may be available in Belgium.

Qualifications

• Minimum 3 years of clinical trial monitoring experience or equivalent per CTI requirements.
• Bachelor's degree or higher in nursing, pharmacy or allied health; RN with required experience acceptable.
• Experience conducting clinical studies in hospital, pharmaceutical or CRO environments.

Responsabilités

• Serve as main CTI contact for assigned study sites.
• Conduct PSV, SIV, IMV and COV visits with timely, quality deliverables.
• Assist with study start-up activities including feasibility and site selection.
• Collect, review and track essential/regulatory documents.
• Monitor site status and lead CRA training and mentoring.
• Oversee IP storage, dispensation and accountability.
• Collaborate with Regulatory Affairs and Ethics Committees as needed.
• Create subject enrollment strategies and support data management activities.

Connaissances

Clinical trial monitoring

GCP compliance

CRO experience

Formation

Bachelor's degree or higher in allied health or nursing

RN with Associate's Degree

3-year Nursing Diploma with clinical nursing experience

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 Bring:

• At least 3 years of clinical trial monitoring experience or equivalent experience as determined by CTI Management and Human Resources
• 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, visitwww.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.

Important Note

In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach 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 LinkedIn page.

Please Note

• We will never communicate with you via Microsoft Teams or text message
• We will never ask for your bank account information at any point during the recruitment process