Home Healthcare CLINICAL STUDY NURSE Freelance About this role 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.
The Study Nurse coordinates and manages clinical studies with drugs, medical devices and cosmetics as Study Nurse under the supervision of the Principal Investigator (PI) in cooperation with the TFS In-house Clinic study team according to the policies and Standard Operating Procedures of TFS and in compliance with Good Clinical Practice as well as with the national and international regulations for clinical studies and data protection.
Key Responsibilities Study Set-up:
Complete feasibility questionnaires from Sponsors
Prepare and attend Pre-study visits
Complete the site qualification questionnaire for EC submission
Participate in the investigator meetings of the Sponsors
Plan and attend Site Initiation Visits
Support patient recruitment in collaboration with the investigators
Study Conduct according to the protocol-related tasks delegated by the PI:
Coordinate, prepare and conduct patients visits according to the study protocol and support the investigators also in screening activities
Conduct diagnostic tests such as vital signs, etc.
Collect and process biological samples
Manage laboratory shipping logistics in accordance with ICAO/IATA Dangerous Goods Regulation
Dispense and administer the Investigational Medicinal Product to study participants following the instructions of the investigators
Manage the Drug Accountability including storage, preparation of the Investigational Medicinal Product
Main contact person for communication with study participants, CRAs and Sponsors
Manage patients reimbursements and investigator fees
Study project documentation:
Prepare and maintain patient files for source documentation
Capture Source Data in various electronic or paper-based Data Capture Systems
Resolve Data Queries in collaboration with the investigators
Maintain the Investigator Site Files
Assist in Serious Adverse Event reporting
Prepare, support and post-process monitoring visits and audits/inspections
Archive study documents
Qualifications
Work Experience as Study Nurse (2 years ideally)
Excellent organizational skills, ability to prioritise and handle multiple competing priorities and timelines
Excellent verbal and written communication skills
Ability to work independently and in a team
Knowledge of the Good Clinical Practice regulations and IATA requirements
Very good command of written and spoken English
Good knowledge of MS Office
Willingness to travel on occasion
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.
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