Senior Clinical Research Associate – m/f/d

🔥 3 minutes ago

🇩🇪 Germany – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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/or remotely, and close out study sites during study conduct • Monitor clinical trials according to TFS and/or sponsor SOPs, GCP and ICH guidelines, and applicable regulations • Perform monitoring activities to assess subject safety, data integrity, and quality • Verify informed consent procedures and protocol requirements • Review electronic or paper CRFs and subject source documentation for validity and accuracy • Verify management and accountability of investigational product • Report monitoring visit actions, findings, and corrective and preventive actions; update tracking systems and escalate issues • Provide sites with identified issues and action items • Deliver site documents to the eTMF or paper TMF • Verify Investigator Site File maintenance according to applicable guidelines and requirements • Update CTMS and other project systems with accurate site-level information • Participate in audit and/or inspection preparation, participation, and follow-up • Order, ship, and reconcile clinical investigative supplies when applicable • Assist Clinical Research Managers or Project Managers with project tracking, monitoring plans, monitoring report reviews, and CRA resource management • Perform Assessment Site Visits when requested • Mentor CRAs • Develop and implement therapeutic-area training for CRAs and project team members • Participate in capabilities presentations

🎯 Requirements

• Bachelor’s Degree, preferably in life science or nursing; or equivalent • More than 3 years of experience as a CRA, including relevant on-site monitoring experience • Able to work in a fast-paced environment with changing priorities • 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 • Excellent written and verbal communication skills • Fluent in English and German • Excellent organizational skills • Technology savvy with good software and computer skills • Ability to manage complex or early phases studies • Ability and willingness to travel up to 60–80%, including overnight and abroad travel if applicable • Self-awareness, resoluteness, flexibility, collaborative mindset, proactivity, analytical approach, attention to detail, coachability, motivation to take on new challenges, facilitation of discussion, and diplomacy in difficult situations • Ability to take ownership of assigned tasks

🏖️ Benefits

• Competitive compensation package • Comprehensive benefits • Opportunity for personal and professional growth • Collaborative and innovative work environment • Team focused on making a difference in patients’ lives

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