Senior Clinical Research Associate

🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

⏱ Part Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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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 clinical study sites • Monitor clinical trials according to TFS and/or sponsor SOPs, GCP, ICH guidelines, and applicable regulations • Perform monitoring activities to assess 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 timely 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 the eTMF or paper TMF and verify Investigator Site File maintenance • Participate in audit or 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 • More than 3 years of experience as a CRA, including relevant on-site monitoring experience • CRA experience in Muscular Dystrophy is required • CRA experience in Gene Therapy or pediatric studies would be an advantage • 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 • Excellent organizational skills • Technology savvy with good software and computer skills • Ability to manage complex or early-phase studies • Ability and willingness to travel 60–80%, including overnight and international travel when applicable • Ability to work in a fast-paced environment with changing priorities

🏖️ Benefits

• Competitive compensation package • Comprehensive benefits • Personal and professional growth opportunities • Collaborative and innovative work environment • Opportunity to make a difference in patients’ lives