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.
As part of our Functional Solutions team, you will be dedicated to one sponsor, a global pharmaceutical or biotechnology company that is an industry leader within its therapeutic area.
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) or completed vocational training as Nurse, Medical Documentation Assistant, Medizinische Fachkraft (MFA) or similar health profession
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 opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the lives of patients.
Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. Together, we make a difference.
A Bit More About Us
Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service global CRO, we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology and Ophthalmology.
Securing the Path from Science to Life