Clinical Research Associate 2

Emerald Clinical; Roma; Ibrido; EUR 42.000 - 60.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive pay

Hybrid/Remote work

Career growth

Wellbeing programs

Global opportunities

Descrizione del lavoro

Emerald Clinical Trials is seeking a Clinical Research Associate 2 (CRA2) to join the Clinical Operations team in our Rome, Italy office or remote in selected roles. You will monitor sites, manage regulatory packages, budgets, and TMF filing to ensure compliance and timely trial delivery.

Ideal candidate has 2–5 on-site monitoring experience, solid knowledge of ICH-GCP, and strong communication and problem-solving skills.

Competenze

• Requires a related science or healthcare discipline.
• 2–5 years on-site monitoring and site management experience in clinical trials.
• Solid knowledge of ICH-GCP and regulatory requirements.
• Strong negotiation, communication, and problem-solving skills.

Mansioni

• Coordinate identification, feasibility, and selection of investigators and sites.
• Perform monitoring activities per the Monitoring Plan and complete visit reports on time.
• Plan and conduct site evaluation visits and report findings for site selection.
• Prepare regulatory packages, import/export updates, and Ethics Committee submissions.
• Negotiate site budgets and oversee contracts and payments.
• Plan and conduct site initiation visits.
• Develop and maintain monitoring tools and documents.
• Educate site staff on protocol, product, and trial requirements; ensure TMF readiness.

Conoscenze

Negotiation

Critical thinking

Problem solving

Decision making

Strategic thinking

Interpersonal skills

Formazione

Related science/healthcare discipline

Descrizione del lavoro

Who We Are

Emerald Clinical Trials is a global leader in clinical research, partnering with over 160 biotech companies and 15 of the world’s top 20 pharmaceutical firms. Headquartered in Singapore, we combine scientific excellence with operational expertise to deliver end-to-end clinical trial solutions across all phases, offering Phase I-IV and real-world studies.

With over 25 years of experience and a world-renowned focus in renal research, Emerald Clinical has helped drive medical breakthroughs through deep scientific insight, flawless execution, and an unwavering commitment to quality.

Global Expertise. Local Insight. Real Impact.

Emerald Clinical is where science, speed, and strategy come together to transform healthcare. For over 25 years, we have led the way in clinical research, combining global reach with deep Asia-Pacific expertise and unparalleled local insight to deliver smarter trials and stronger outcomes.

Our 800+ employees that span across Asia-Pacific, Europe, and the Americas are embedded in communities worldwide. We drive faster recruitment, deeper patient engagement, and meaningful results that move medicine forward.

About The Role

The Clinical Research Associate 2 (CRA2) is a member of the Clinical Operations group at Emerald Clinical. The Clinical Operations group is responsible for site management, monitoring tasks, and the operational support of clinical trials. The group allocates resources to projects as appropriate to assist with implementing project plans and to ensure compliance with regulatory requirements and Standard Operating Procedures (SOPs).

Your Responsibilities

• Coordinate the identification, feasibility assessment, and selection of investigators and sites to undertake the trial.
• Complete all monitoring activities per the Monitoring Plan along with completing monitoring visit reports, accurately and within the predetermined timeframe.
• Prepare, plan, organize, and conduct site evaluation visits and report on these visits to assist in site selection.
• Prepare, submit, and/or liaise with regulatory specialist colleagues, regarding the preparation of regulatory packages, importation/exportation requirements, and updates of Ethics Committee packages.
• Negotiate site budgets, coordinate for site contract execution, track invoicing, and ensure timely site payments.
• Prepare, plan, organize, and conduct site initiation visits.
• Develop and maintain appropriate monitoring tools and project-specific documents.
• Motivate and train investigators to ensure that the trial site personnel have a good understanding of the protocol, investigational product, and requirements of the trial so they can fulfill their obligations to conduct the trial accurately and to deadlines. Collect, review, and approve essential documents from trial sites, to ensure quality and compliance, and code documents for Trial Master File (TMF) filing.
• Reconcile contents of in-house TMF and site’s Investigator Site Files.
• Coordinate distribution, tracking, handling, and destruction of investigational product and other trial supplies per site/trial requirements.
• Maintain trial information using the clinical trial management system and any other tracking and reporting tools for the trial.
• Support strategies to boost recruitment efforts.

About You

• Qualifications in a related science or health care discipline.
• Previous experience in clinical trials within an academic, CRO, or pharmaceutical environment with 2-5 experiences in on-site monitoring and site management experience is mandatory.
• Demonstrate practical knowledge of ICH-GCP guidelines and global and local ethical and regulatory research requirements.
• Display competence in the following technical areas: ethical and participant safety considerations, site start-up management, site conduct management, risk management, quality management, supply management, scientific concepts and clinical research design, and issue escalation management.
• Demonstrate competence in the following business skill areas: negotiation and conflict resolution, critical thinking, problem-solving, decision making, and strategic thinking.
• Demonstrate solid interpersonal communication, presentation skills, and flexibility to work well within a multi-disciplinary team both autonomously and with a wide range of varying stakeholders.
• Ability to be flexible and adaptable in the face of changing organizational priorities and ambiguous environments.
• Ability and willingness to travel.

Why Join Us?

At our core, Emerald Clinical Trials is committed to transforming clinical research by putting people first - both patients and our employees. By joining our team, you’ll be part of a global network of passionate professionals working together to deliver better research and outcomes for millions worldwide.

Here’s What Makes Us Stand Out

• Purpose-Driven Work: You’ll contribute to clinical trials that genuinely improve lives, with a focus on therapies in renal, cardiometabolic, and oncology.
• Global Reach, Local Expertise: Our teams connect with local communities, building trust and meaningful engagement for every trial.
• Collaboration and Innovation: Work in a culture that values diverse perspectives and creative solutions to solve global health challenges.

What We Offer

We understand that great work happens when people feel valued and supported. That’s why we provide:

• Competitive Compensation: A tailored salary and benefits package to reflect your skills and experience.
• Flexibility: Enjoy hybrid or remote working arrangements, depending on your location and role.
• Career Growth: Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role.
• Employee Wellbeing: Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events.
• Global Opportunities: Be part of a company with international reach, offering you exposure to diverse projects and clients.

We are an equal-opportunity employer and encourage applications from all qualified candidates.