Senior Clinical Research Associate

🕒 2 days ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• Perform all aspects of study site monitoring, including routine monitoring and closeout of clinical sites • Maintain study files and conduct pre-study and initiation visits • Liaise with vendors and manage site activities according to project plans • Ensure study staff receive proper materials and instructions • Verify informed consent procedures and protocol compliance to protect study patients • Review source documents and ensure data integrity in Case Report Forms and other data collection tools • Monitor data for missing or implausible information • Perform monitoring tasks efficiently according to SOPs, guidelines, and travel policy • Ensure audit readiness at the site level • Prepare accurate and timely trip reports • Manage small projects under Project Manager/Director direction • Serve as lead monitor for protocols or projects and assist with monitoring plans and trip report review • Review project progress and initiate actions to meet objectives • Organize and present at Investigator Meetings • Participate in protocol, Case Report Form, and clinical trial report development • Collaborate with internal work groups to evaluate needs, resources, and timelines • Act as contact for clinical trial supplies and vendors • Manage clinical trial registries according to project plans • Conduct feasibility work and Quality Control visits when requested • Recruit investigators and prepare ethics committee submissions and regulatory notifications • Translate study documentation and organize meetings • Negotiate study budgets with investigators and assist the legal department with agreements • Track and follow up on Serious Adverse Events and produce reports and narratives • Perform CRF review, generate and resolve queries in clinical data management systems • Train, mentor, and develop new employees through activities such as co-monitoring • Coordinate designated clinical projects as a Local Project Coordinator and act as a local client contact when assigned • Perform other duties as assigned

🎯 Requirements

• University or college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology • Minimum of 3 years of relevant clinical research experience in pharmaceutical or CRO industries may substitute for the education requirement • Three (3) years of Clinical Monitoring experience • Thorough knowledge of regulatory requirements, including a basic understanding of regulatory requirements in other countries • Thorough understanding of the drug development process • Fluent in the local office language and English, written and verbal • Full understanding of Serious Adverse Event (SAE) reporting, report and narrative production, and SAE follow-up • Advanced site monitoring skills • Advanced study site management skills • Advanced registry administration skills • Ability to work with minimal supervision • Good planning and organization skills • Good computer skills and working knowledge of a range of computer packages • Advanced verbal and written communication skills • Ability to train and supervise junior staff • Ability to resolve project-related problems and prioritize workload for self and team • Ability to work within a project team and effectively in a matrix environment • Valid driver's license • One or more years of additional experience in a related field preferred • Local project coordination and/or project management experience preferred

🏖️ Benefits

• Travel, including air travel, may be required and is an essential function of the job • 60–80% overnight travel • Equal employment opportunity and accommodations support

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