Clinical Research Associate 2

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

📋 Description

• Oversee the identification of investigators and sites, conduct feasibility assessments, and finalize selections.

• Execute monitoring tasks in accordance with the Monitoring Plan.

• Accurately complete monitoring visit reports within established deadlines.

• Organize, conduct, and report on site evaluation visits.

• Prepare and submit regulatory documentation and updates to the Ethics Committee while collaborating with regulatory experts.

• Manage the requirements for the importation and exportation of trial materials.

• Negotiate site budgets and facilitate the execution of site contracts.

• Monitor invoicing processes and ensure prompt payments to sites.

• Plan, organize, and execute site initiation visits.

• Create and maintain monitoring tools as well as project-specific documentation.

• Inspire and educate investigators and trial site staff on protocols, investigational products, and trial requirements.

• Collect, evaluate, approve, and categorize essential trial-site documents for inclusion in the Trial Master File.

• Reconcile contents of the in-house Trial Master File with the Investigator Site File.

• Manage the distribution, tracking, handling, and disposal of investigational products and trial supplies.

• Keep trial information updated in the clinical trial management system along with other tracking and reporting tools.

• Assist in developing strategies to enhance recruitment efforts.

⛳️ Requirements

• A degree in a relevant scientific or healthcare discipline.

• 2–5 years of experience in on-site monitoring and site management within an academic, CRO, or pharmaceutical setting.

• Practical understanding of ICH-GCP guidelines.

• Familiarity with global and local ethical and regulatory research standards.

• Proficiency in ethical and participant safety considerations, site start-up management, site conduct management, risk management, quality management, supply management, scientific concepts, clinical research design, and issue escalation management.

• Strong negotiation and conflict resolution skills, along with critical thinking, problem-solving, decision-making, and strategic thinking abilities.

• Excellent interpersonal communication and presentation skills.

• Capability to work independently as well as collaboratively within a multi-disciplinary team comprising various stakeholders.

• Adaptability and flexibility in response to changing organizational priorities and ambiguous situations.

• Willingness and ability to travel as needed.

🏝️ Benefits

• Customized salary and benefits package that reflects skills and experience.

• Options for hybrid or remote work arrangements, based on location and role.

• Access to educational opportunities and a global network of scientific leaders.

• Employee well-being programs and initiatives that promote work-life balance, health, and team connection.

• Participation in global engagement surveys.

• Recognition programs to acknowledge achievements.

• Team-building activities and events.

• Opportunities to work on diverse international projects and with various clients.