Lead Clinical Research Associate

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.

Join Our Team as a Lead Clinical Research Asosciate

About this role

As part of our Clinical Operations team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

The Lead Clinical Research Associate is responsible for coordinating and overseeing the country and site management activities during study conduct, according to company policies, SOPs and regulatory requirements in addition to financial and contractual obligations.

Key Responsibilities: 

• Support the Project Manager being responsible and accountable for overseeing all aspects of monitoring and site Management activities ensuring compliance with ICH/GCP guidelines, SOPs and protocol requirements.
• Lead, manage and guide CRAs being responsible for training and quality oversight of site management activities while proactively identifying potential operational issues and ensuring study deliverables.
• Development of Study Monitor plans, Monitor and Site Training plans, verification initiatives, coordinating Study Investigator Meetings and reviewing site and country Study Reports.
• Ensure study processes, procedures and expectations correspond to the practicality of conducting the trial from study feasibility through to close out.
• Serve as initial point of contact for the monitoring team and support them with investigative site personnel liaison.
• Implement monitoring/recruitment plans and support also the design of CRF completion guidelines.
• Perform co-monitoring visits as part of the monitoring team quality oversight.
• Review and approve site visit reports (PSV, SIV, MV and COV) and act as first point of contact for issue escalation ensuring the proper resolution and action plan definition and follow up.
• Review CRA Site Visits calendar ensuring monitoring visits (both remotely and on site) are being scheduled and conducted following monitoring plan frequency.

Qualifications: 

• Bachelor’s Degree, preferably in life science or nursing; or equivalent.
• Minimum 3 years of experience as CRA including relevant on-site monitoring experience.
• Able to work in a fast paced environment with changing priorities.
• Understand the basic medical terminology and science associated with the assigned drugs and therapeutic areas.
• Possess the understanding of Good Clinical Practice regulations, ICH guidelines.
• Ability to work independently as well as in a team matrix organization and multiple projects.
• Excellent written and verbal communication skills as well as computer skills.
• Excellent organizational and Line Management skills.

What We Offer

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

A Bit More About Us

Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.