Senior Clinical Research Associate

🔥 13 hours ago

🇮🇹 Italy – Remote

💵 €42k - €58k / year

⏳ Contract/Temporary

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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TFS HealthScience - Contract Research Organization

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2007

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance clinical development. They offer a wide range of solutions including phase I-III clinical development, real-world evidence (Phase IV) studies, and strategic resourcing solutions. TFS HealthScience specializes in multiple therapeutic areas such as dermatology, internal medicine, neuroscience, oncology and hematology, ophthalmology, pediatrics, rare diseases, and orphan drugs. They aim to bring treatments to patients faster by combining their full-service capabilities and global reach with the flexibility and personalized approach of a mid-size CRO.

📋 Description

• Function operationally as a member of a Project Team • Initiate, monitor on-site and remotely, and close out clinical trial study sites • Monitor clinical trials according to company and sponsor SOPs, GCP, ICH guidelines, and applicable regulations • Perform monitoring activities to ensure subject safety, data integrity, and quality • Verify informed consent procedures and protocol compliance • Review electronic or paper CRFs and source documentation for validity and accuracy • Verify management and accountability of investigational product • Prepare Monitoring Visit Reports, document findings and corrective/preventive actions, update tracking systems, and escalate issues • Provide sites with identified issues and required action items • Deliver site documents to eTMF or paper TMF and verify Investigator Site File maintenance • Participate in audit and inspection preparation and follow-up • Order, ship, and reconcile clinical investigative supplies when applicable • Update CTMS and other project systems with accurate site-level information

🎯 Requirements

• 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 early-phase study (Phase I or II) • Understanding of basic medical terminology and science associated with assigned drugs and therapeutic areas • Understanding of Good Clinical Practice regulations and ICH guidelines • Ability to work independently and in a team matrix organization • Strong written and verbal communication skills • Fluent in English • Excellent organizational skills • Technology savvy with good software and computer skills • Ability and willingness to travel up to 60–80%, including overnight and abroad travel if applicable

🏖️ Benefits

• Competitive compensation package • Comprehensive benefits • Personal and professional growth opportunities • Lunch vouchers • Health insurance • Pension • Car allowance where applicable • Collaborative and innovative work environment