Senior Clinical Research Associate

at  TFS HealthScience

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) dedicated to partnering with biotechnology and pharmaceutical companies throughout their entire clinical development journey. With expertise in full-service capabilities, resourcing, and Functional Service (FSP) solutions, we’re looking for a talented Clinical Research Associate (CRA) contractor to join our team in Italy.

QUALIFICATIONS

• Experience: Minimum of 5 years of clinical monitoring experience within a CRO, biotech, or pharmaceutical environment.
• Education: A Bachelor’s degree in a related field (Life Sciences, Nursing, etc.).
• Regulatory Knowledge: Strong understanding of ICH-GCP guidelines and regulatory requirements in Italy.
• Technical Skills: Proficiency in clinical trial management systems (CTMS) and eTMF platforms.
• Communication: Excellent written and verbal communication skills with the ability to interact effectively with site staff and sponsor representatives.

ABOUT THE ROLE

As a Senior Clinical Research Associate with TFS HealthScience, you will be a vital part of our SRS/FSP team, working exclusively with a global biotech sponsor. You will play a crucial role in ensuring the quality and integrity of clinical trials, driving them forward from start to finish.

KEY RESPONSIBILITIES

• Submission & Amendment Support: Assist with initial and ongoing submissions, including amendments to ethics committees.
• Regulatory Reporting: Manage periodic reporting to ethics committees, including the reporting of safety events.
• Pre-activation & SIV Support: Contribute to site pre-activation activities and support Site Initiation Visits (SIVs).
• Monitoring & Site Management: Conduct both onsite monitoring and periodic central monitoring to ensure trial integrity; manage site relationships and processes.
• Documentation & Closeout: Maintain the eTMF (electronic Trial Master File) and lead closeout visits, ensuring compliance and completeness.