Study Coordinator
Copenhagen - Denmark
Job Summary
We welcome applications from candidates interested in either full-time employment (with TFS) or contractor/freelance arrangements.
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 Site Coordinator is part of the Site Coordinators Unit within Strategic Resourcing Solutions Unit
and will work operationally as a member of the Study Team at the investigational site.
The Site Coordinator will be provided with the necessary Study Protocol and Procedures training by
the Principal Investigator as stated by the current legislation.
Under the Principal Investigator supervision the Site Coordinator will be delegated in performing
assigned Site Study tasks working to facilitate the Principal Investigator (PI) job contributing to the
quality of the study providing appropriate support to reach the milestones pro-actively recruiting new patients and speeding up any data-entry process.
Work is conducted according to company policies SOPs and regulatory requirements.
As part of our SRS/FSP 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
Data Entry
Queries resolution
Assist with SAE notification
Help investigator with patient recruitment
Facilitate Ethics Committee submissions
Attend Monitoring Visits Audits and Inspections if required
Investigator File updating
Patient visits schedule
Study Drug Accountability and Dispensing logs
Patients expenses payment
Assist in investigators meetings or training when required
Sample Management not including any invasive procedure or contact with dangerous samples or substances
Qualifications
Clinical or life science background
GCP certification
Site coordination experience: visit scheduling monitoring visit prep safety reporting
eCRF / EDC system familiarity (Medidata Rave Viedoc Oracle InForm)
Strong administration and document management skills
Local language mandatory (Danish)
Comfortable working across several sites (2-3) within the country
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.
About Company
TFS HealthScience is a global, mid-sized contract research organization (CRO) partnering with biotechnology and pharmaceutical companies across the full clinical development lifecycle. Our expertise spans full-service clinical development, project-based support, strategic resourcing, ... View more