Clinical Research Associate II

This is a fully remote position, open to applicants in Belgium.

📋 Description

• Act as the primary CTI contact for designated study sites.

• Execute pre-study assessments, site initiation, interim monitoring, and close-out visits.

• Fulfill site visit deliverables as per the Monitoring Plan, timelines, regulatory standards, SOPs, and ICH GCP.

• Assist with or oversee feasibility studies, study initiation, and site selection processes.

• Gather, review, and maintain essential and regulatory documents.

• Engage in meetings and presentations with investigators, clients, and project teams.

• Develop and implement strategies for subject enrollment.

• Ensure appropriate storage, dispensing, and accountability of Investigational Product and trial materials.

• Manage site operations and provide status updates to the Clinical Project Manager.

• Conduct remote monitoring and associated study tasks.

• Monitor subject status, CRF retrieval/source document verification, regulatory documents, and Investigational Product via systems and reports.

• Contribute to project-specific initiatives as a member of the Project Team.

• Take part in the development of CRFs, subject worksheets, Monitoring Plans, and additional study documentation.

• Translate, customize, and review Patient Information Sheets, Informed Consent forms, protocol summaries, and other relevant documents.

• Assist the Regulatory Affairs Study Start-up Team with submissions and follow-ups to Ethics Committees and Regulatory Authorities.

• Provide regular updates to the Sponsor/Client.

• Support or oversee site contract negotiations, Investigator payments, and tracking of site payments.

• Manage the ISF and TMF for assigned study sites.

• Identify site-related issues, implement corrective and preventive measures, or escalate as necessary.

• Collaborate with Clinical Data Management for data-cleaning tasks.

• Mentor and train CRAs, including conducting training and assessment visits.

• Serve as Lead CRA for designated projects.

• Identify and suggest process enhancements.

• Offer therapeutic-area expertise to team members.

⛳️ Requirements

• Minimum of 3 years of experience in clinical trial monitoring or equivalent experience as defined by CTI Management and Human Resources.

• Proficient in English.

• Bachelor's Degree or higher in an allied health field such as nursing, pharmacy, or health/natural science; or an RN with an Associate's Degree; or a 3-year Nursing Diploma with at least 2 years of clinical nursing experience; or equivalent experience as determined by CTI Management and Human Resources.

• Prior experience conducting clinical research studies in a hospital environment, pharmaceutical company, or as a CRA.

• Compliance with relevant regulatory standards, SOPs, and ICH GCP.

• Capability to complete both general and study-specific training.

• Proficient in conducting PSV, SIV, IMV, and COV site visits and delivering results within Monitoring Plan timelines.

• Skilled in managing essential/regulatory documents, ISF, and TMF.

• Competent in managing Investigational Product and trial-related materials.

• Ability to support enrollment strategies, remote monitoring, data cleaning, and regulatory submissions.

• Capacity to mentor/train CRAs and act as Lead CRA.

• Proficient in performing necessary translations, customizations, and document reviews.

🏝️ Benefits

• Structured mentoring program and leadership courses.

• Ongoing education and training opportunities.

• Tuition reimbursement.

• Dedicated training department.

• Award-winning company culture.

• Support for work-life balance.

• Comprehensive health benefits.

• Vacation packages.

• Hybrid work-from-home options.

• Paid parental leave.

• CTI Cares program.