Posted 3w ago

Study Coordinator

@ TFS HealthScience
Stockholm or Lund or Askersund or Gothenburg or Malmö or Solna or Uppsala
OnsiteFull Time
Responsibilities:Data entry, Query resolution, SAE notification
Requirements Summary:Clinical or life science background; GCP certification; site coordination experience; eCRF/EDC familiarity; strong administration and document management; local language Swedish.
Technical Tools Mentioned:Medidata Rave, Viedoc, Oracle InForm
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Job Description

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 (Swedish)

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.