Study Coordinator
About this role
STUDY COORDINATOR FREELANCE/CONTRACTOR - 0.5 FTE
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.
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
Requirements
- Clinical or life science background
- GCP certification
- Site coordination experience: visi