Lead Clinical Research Associate at TFS HealthScience

Rome, Lazio, Italy -

Full Time

Start Date

Immediate

Expiry Date

15 Mar, 26

Salary

0.0

Posted On

15 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research, Site Management, Monitoring, Good Clinical Practice, ICH Guidelines, Oncology, Training, Quality Oversight, Project Management, Communication, Organizational Skills, Problem Solving, Team Collaboration, Medical Terminology, Recruitment Planning, Trial Master File Management

Industry

Pharmaceutical Manufacturing

Description

LEAD CRA FREELANCE 0.5 FTE - REMOTE (ITALY) LEAD CRA FREELANCE 0.5 FTE - REMOTE (ITALY) LEAD CRA FREELANCE 0.5 FTE - REMOTE (ITALY) 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. 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. Update the Project Manager with status of sites and countries and ensure a proper escalation of any issue detected at site/country level. Ensure documents remain current during the course of the trial and ensure proper maintenance of Trial Master File being responsible of QC when delegated by Project Manager. When delegated by Project Manager, track and approve investigators payments. Assist Project Manager in CRA training program, training CRAs on study procedures and requirements and ensuring a proper handover when there is a replacement of CRA. 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. Experience in Phase 4 / RWE / Non-Interventional Studies Experience in Oncology, ideally Breast Cancer 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 Ability and willingness to travel up to 10-20% 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.

Responsibilities

The Lead Clinical Research Associate is responsible for overseeing monitoring and site management activities, ensuring compliance with guidelines and protocols. They will lead and guide CRAs, develop study monitor plans, and serve as the initial point of contact for the monitoring team.