Clinical Research Associate II – Senior Clinical Research

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

📋 Description

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

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

• Complete site visit deliverables with high quality and in line with Monitoring Plan timelines.

• Support or manage study start-up activities, including feasibility assessments, pre-study tasks, and site selection.

• Gather, evaluate, and monitor essential and regulatory documents.

• Engage in mandatory general and study-specific training sessions.

• Participate in meetings with investigators, clients, and project teams, including delivering presentations.

• Develop and apply subject enrollment strategies for the assigned sites.

• Ensure appropriate storage, distribution, and accountability of investigational products and trial-related materials.

• Execute site management duties and provide continuous site status updates to the Clinical Project Manager.

• Carry out remote monitoring in accordance with the study-specific Monitoring Plan.

• Utilize systems and reports to track subject status, CRF retrieval, source document verification, regulatory documents, and investigational products.

• Assist with project-specific tasks as a member of the Project Team.

⛳️ Requirements

• 3 - 5 years of clinical research experience as a CRA or in a related field.

• Background in life sciences.

• Strong understanding of ICH-GCP and regulatory requirements.

• Proficiency in spoken and written English at a minimum Level B2.

• Capability to conduct pre-study, site initiation, interim monitoring, and close-out visits.

• Ability to fulfill site visit deliverables within specified timelines and according to monitoring plans.

• Familiarity with relevant regulatory requirements, SOPs, and ICH GCP guidelines.

• Competence to assist with or supervise study start-up activities, feasibility assessments, pre-study tasks, and site selection.

• Proficiency in collecting, reviewing, and monitoring essential and regulatory documents.

• Ability to complete both general and study-specific training programs.

• Skill in creating and implementing subject enrollment strategies.

• Competence in managing investigational products and trial-related materials.

• Ability to conduct remote monitoring and utilize systems and reports for tracking study data.

• Capability to engage in meetings with investigators, clients, and project teams, including making presentations.

🏝️ Benefits

• Structured mentoring program.

• Leadership development courses.

• Dedicated training department.

• Ongoing educational support.

• Hybrid work opportunities.

• CTI Cares community initiatives and global giving opportunities.

• Work that contributes to advancing medicine and the development of life-changing treatments.