(Senior) Clinical Research Associate

TFS HealthScience; Roma; Remoto; EUR 42.000 - 58.000; Tempo pieno

Vantaggi offerti da questo lavoro

Lunch vouchers

Health insurance

Pension

Car allowance where applicable

Descrizione del lavoro

TFS HealthScience seeks a Clinical Research Associate (CRA) to join our team as a home-based professional in Italy. You will monitor sites, ensure subject safety and data integrity, and ensure compliance with GCP/ICH guidelines.

The role requires familiarity with regulatory processes and strong collaboration with project teams. The position offers a competitive package with opportunities for professional growth within a global CRO, while working remotely from Italy and traveling up to 80% as

Competenze

• Bachelor’s degree in life science or nursing or equivalent
• Fluent in English with strong communication skills
• Ability to work independently and in a matrix environment
• Willingness to travel up to 60–80% (overnight and abroad)

Mansioni

• Monitor on-site and remote clinical trials in accordance with GCP and ICH guidelines
• Perform monitoring activities to ensure subject safety and data integrity
• Verify informed consent procedures and regulatory requirements
• Review CRFs and source documents for accuracy
• Manage Investigational Product accountability and site documentation
• Report monitoring findings and contribute to CAPA plans
• Coordinate with sites, eTMF/ISF maintenance and CTMS updates
• Assist with audits/inspections as needed
• Coordinate supply orders and reconciliation if applicable
• Maintain site-level information across project systems

Conoscenze

Fluent English

Travel flexibility

Formazione

Bachelor’s degree in life science or nursing

Descrizione del lavoro

CRA / SENIOR CRA - Homebased (Italy)

Temporary (1 year with possibility to be extended)

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.

Join Our Team as a Clinical Research Associate home-based in Italy

About This Role

The Clinical Research Associate (CRA) is part of Strategic Resourcing Solutions (SRS) within TFS Health Science and will function operationally as a member of a Project Team and is responsible for the initiation, on–site and/or remote monitoring, close out of study sites during study conduct, according to company policies, SOPs and GCP and ICH guidelines and other regulatory requirements.

Key Responsibilities

• Monitor on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard Operating Procedures GCP and ICH guidelines and applicable regulatory regulations.
• Perform all required monitoring activities at the study sites to assess and ensure subjects safety, data integrity and quality.
• Verify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations.
• Review CRFs (electronic or paper) and subject source documentation for validity and accuracy
• Verify proper management and accountability of Investigational Product.
• Timely reporting of actions taken during monitoring visits in Monitoring Visit Report including findings, corrective and preventive actions already taken and update applicable tracking systems, as required; escape observed deficiencies and issues as appropriate.
• Providing site with the listing of issues identified during monitoring visit and action items which will need to be addressed in a timely manner.
• Timely delivering site documents to eTMF or paper TMF; verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and ICH guidelines and local regulatory requirements.
• Participate in audit and/or inspection, its preparation and follow-up activities, as needed.
• Order, ship, and reconcile clinical investigative supplies for study sites, if applicable
• Update CTMS and all other required by projects systems with accurate site level information

Qualifications

• Bachelor’s Degree, preferably in life science or nursing; or equivalent
• At least 3 years of experience monitoring clinical trials in Oncology, including at least one involved in early-phase studies (Phase I or II).
• Able to work in a fast-paced environment with changing priorities.
• Understand basic medical terminology and science associated with the assigned drugs and therapeutic areas.
• Possess the understanding of Good Clinical Practice regulations, ICH guidelines.
• Ability to work independently as well as in a team matrix organization.
• Strong written and verbal communication skills.
• Fluent in English
• Excellent organizational skills
• Technology savvy and good software and computer skills
• Soft skills: Self-awareness, resolute, flexibility, proactivity, collaborative mindset, analytic approach, and attention to detail
• Ability and willingness to travel up to 60-80%, overnight and abroad if applicable.

What We Offer

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

Salary: 42.000-58.000 gross/year (depending on the level of experience), in line with CCNL Terziario-Servizi (Level III), plus benefits (lunch vouchers, health insurance, pension, and car allowance where applicable

A Bit More About Us

Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.