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.
As part of our SRS/FSP team, you will be dedicated to one sponsor.
Please, keep in mind that this is a Freelance opportunity for approximately 0.7 FTE with sites in both Germany and Switzerland.
Key Responsibilities
* Monitor clinical trials on-site and remotely in accordance with TFS/client SOPs, FDA regulations, and GCP/ICH guidelines
* Review CRFs (paper or electronic) and subject source documentation for validity and accuracy; generate queries to resolve data issues
* Identify site problems or deficiencies and report them to management through trip reports, memos, and communication with the Project Manager or Lead CRA
* Initiate corrective actions as directed by the supervisor
* Contribute to Ethics Committee/IRB application submissions and prepare required documentation in collaboration with the CTA and as directed by the Lead CRA/Project Manager
* Participate in contract handling and negotiation under direction of the Lead CRA/Project Manager
* Set up the Investigator Site File (ISF) and Study Master File (SMF), or support the CTA in doing so, and distribute materials to investigational sites
* Collaborate with the study team on SMF maintenance
* Order, ship, and reconcile clinical investigational supplies for study sites, if applicable
* Coordinate ordering and shipment of study supplies to sites
* Prepare and submit status reports as directed by the Lead CRA/Project Manager
* Review and support site staff in maintaining the SMF
* Review Informed Consent Forms for essential elements and protocol compliance
* Update CTMS with site and study information
* Audit data in tables and text of clinical summaries (as applicable)
Qualifications:
* Bachelor’s degree, preferably in life sciences or nursing, or equivalent
* Experience in Medical Devices
* Solid understanding of Good Clinical Practice (GCP) regulations and ICH guidelines
* Ability to work independently and within a team/matrix organization
* Excellent written and verbal communication skills
* Strong organizational skills
* Ability and willingness to travel
* Experience with Medical Device submissions in both Germany and Switzerland is mandatory.
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 satisfactionBy 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.