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 Senior Clinical Research Associate in Portugal.
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 Senior Clinical Research Associate is responsible for responsible for the initiation, on-site and remote monitoring and termination of investigative sites during study conduct, according to company policies, SOPs and regulatory requirements.
The Senior Clinical Research Associate may assist the Project Manager in certain aspects of project activities which may include project tracking, monitoring plans, review of monitoring reports and CRA resources management.
The Senior Clinical Research Associate may also conduct all stages of site monitoring (feasibility, pre-study, initiation, interim, and close-out). Ability to travel as needed; may involve overnight and international travel.
Key Responsibilities:
Monitor on-site and remotely clinical trials in accordance with TFS and/or client company Standard Operating Procedures, FDA regulations, and GCP and ICH guidelines
Review CRFs (paper or electronic) and subject source documentation for validity and accuracy and generate queries to investigational sites/clients to resolve problem data
Identify site problems/deficiencies and bring to the attention of management through trip reporting, memos, and verbal communication with Project Manager or Lead CRA
Initiates corrective action to resolve issues as directed by supervisor
Contribute to the completion of the application to Ethics Committee/IRB, prepare necessary documentation enclosed to the application according to local requirements in cooperation with CTA and directed by Lead CRA/Project Manager
Participate in contract handling and negotiation directed by Lead CRA/Project Manager
Set up ISF and SMF (or cooperate with CTA) and distribute to the investigational sites.
In cooperation with study team, responsible for SMF maintenance
Qualifications:
Bachelor's Degree, preferably in life science or nursing; or equivalent
Minimum 5 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
Excellent written and verbal communication skills - English and Turkish
Excellent organizational skills
Ability and willingness to travel up to 60-70%
What We Offer
We provide a competitive hourly rate 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.
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