Study Coordinator

TFS HealthScience

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profile Job Location:

Copenhagen - Denmark

profile Monthly Salary: Not Disclosed
Posted on: 3 days ago
Vacancies: 1 Vacancy

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.

We welcome applications from candidates interested in either full-time employment (with TFS) or contractor/freelance arrangements.About this roleTFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughou...
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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

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