Clinical Research Associate II

🔥 0 minutes ago

🇧🇪 Belgium – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

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CTI Clinical Trial and Consulting Services

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1999

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

CTI Clinical Trial and Consulting Services is a full-service contract research organization (CRO) that provides clinical trial execution, regulatory strategy, lab and bioanalytical services, real-world evidence generation, and research center management to biotech and pharmaceutical sponsors. With expertise across Phase I–IV studies and complex therapeutic areas (including rare diseases, cell and gene therapy, oncology, neurology, and transplantation), CTI supports study design, site management, patient recruitment, monitoring, safety/pharmacovigilance, biometrics, and quality assurance. Headquartered in Covington, KY, the company emphasizes integrated, patient-centric approaches and global regulatory guidance to accelerate development and bring therapies to patients.

📋 Description

• Serve as main CTI contact for assigned study sites • Conduct pre-study, site initiation, interim monitoring and close-out visits • Complete site visit deliverables according to the Monitoring Plan, timelines, regulatory requirements, SOPs and ICH GCP • Assist with or oversee feasibility, study start-up and site selection activities • Collect, review and track essential and regulatory documents • Participate in investigator, client and project team meetings and presentations • Create and implement subject enrollment strategies • Ensure proper storage, dispensation and accountability of Investigational Product and trial materials • Perform site management and provide site-status updates to the Clinical Project Manager • Conduct remote monitoring and related study activities • Track subject status, CRF retrieval/source document verification, regulatory documents and Investigational Product using systems and reports • Support project-specific activities as a Project Team member • Participate in development of CRFs, subject worksheets, Monitoring Plans and other study documents • Translate, customize and review Patient Information Sheets, Informed Consent forms, protocol synopses and other applicable documents • Support Regulatory Affairs Study Start-up Team with Ethics Committee, Regulatory Authority and related submissions and follow-up • Provide regular updates to Sponsor/Client • Support or oversee site contract negotiation, Investigator payments and site-payment tracking • Manage ISF and TMF for assigned study sites • Identify site issues, implement corrective and preventive actions, or escalate appropriately • Liaise with Clinical Data Management for data-cleaning activities • Mentor/train CRAs, including conducting training/assessment visits • Function as Lead CRA for assigned projects • Identify and propose process improvements • Provide therapeutic-area expertise to team members

🎯 Requirements

• 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 • Adherence to applicable regulatory requirements, SOPs and ICH GCP • Ability to complete general and study-specific training • Ability to conduct PSV, SIV, IMV and COV site visits and complete deliverables within Monitoring Plan timelines • Ability to manage essential/regulatory documents, ISF and TMF • Ability to manage Investigational Product and trial-related materials • Ability to support enrollment strategies, remote monitoring, data cleaning and regulatory submissions • Ability to mentor/train CRAs and function as Lead CRA • Ability to perform required translations, customizations and document reviews

🏖️ Benefits

• Structured mentoring program and leadership courses • Ongoing education and training • Tuition reimbursement • Dedicated training department • Award-winning company culture • Work-life balance support • Generous health benefits • Vacation packages • Hybrid work from home opportunities • Paid parental leave • CTI Cares program