Freelance Senior Clinical Research Associate

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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 as an operational member of a Project Team during clinical study conduct • Initiate, monitor on-site and remotely, and close out study sites • Provide unmasked CRA support for assigned clinical studies • Manage investigational product accountability and oversee unblinded site activities • Monitor protocol compliance, subject safety, data integrity, and data quality • Verify informed consent procedures and protocol requirements • Review electronic or paper CRFs and source documentation for validity and accuracy • Report monitoring visit actions, findings, and corrective/preventive actions; escalate deficiencies as appropriate • Provide sites with identified issues and required action items • Deliver site documents to the eTMF or paper TMF • Verify Investigator Site File maintenance according to GCP, ICH, and local requirements • Update CTMS and other project systems with accurate site-level information • Participate in audit and inspection preparation and follow-up • Order, ship, and reconcile clinical investigative supplies when applicable • Assist Clinical Research or Project Managers with project tracking, monitoring plans, monitoring report reviews, and CRA resource management • Perform Assessment Site Visits when requested • Mentor CRAs and develop therapeutic-area training when applicable • Participate in capabilities presentations

🎯 Requirements

• Bachelor’s Degree, preferably in life science or nursing; or equivalent • More than 5 years of independent on-site monitoring experience • At least 1 year of experience as an unmasked monitor • Ophthalmology experience preferred, ideally in a retina indication • Ability to work in a fast-paced environment with changing priorities • Understanding of basic medical terminology and science related to assigned drugs and therapeutic areas • Understanding of Good Clinical Practice regulations and ICH guidelines • Ability to work independently and within a team matrix organization • Excellent written and verbal communication skills • Fluent in English and the local language • Excellent organizational skills • Technology savvy with good software and computer skills • Self-awareness, resoluteness, flexibility, collaboration, proactivity, analytical approach, attention to detail, coachability, motivation, discussion facilitation, and diplomacy • Ability to take ownership of assigned tasks • Ability to manage complex or early-phase studies • Ability and willingness to travel up to 60–80%, including overnight and international travel when applicable

🏖️ Benefits

• Competitive compensation package • Comprehensive benefits • Opportunity for personal and professional growth • Collaborative and innovative work environment • Opportunity to make a difference in patients’ lives • Applications welcomed from candidates belonging to protected categories under art. 1 L. 68/99