07 set - Roma
Tfs Healthscience
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.
Join Our Team as a Study Start Up Specialist
About this role
- As part of our Study Start Up team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals._
The Study Start Up Specialist is part of the Site Management and Start Up Unit, within TFS Develop and will function operationally as a member of a Project Team being responsible of startup activities according to company policies, SOPs and regulatory requirements in addition to financial and contractual obligations.
The Study Start Up Specialist must contribute to ensure the planned start up plan is executed maximizing the recruitment window of assigned studies. As part of the job function will perform activities associated with feasibility and site identification,
study site initiation process, interact with Ethics Committees or deal with investigator contracts.
Key Responsibilities:
- Performs the startup activities of assigned studies within a country or region ensuring that those are performed on-time, within the scope and in compliance with ICH/GCP guidelines, SOPs and protocol requirements.
- Collect, review, approve process and track regulatory & investigator documents required for study site activation.
- Prepare and complete regulatory process (IEC/IRBs) including ask for requirements to the EC/IRBSs, prepare and collecting specific documentation, submission and amendments, regulatory fees.
- Collaborate with Regulatory department regarding HA/CA submission/notification.
- Main responsible of ensuring the quality control of documentation included in any submission/notification.
- Adapt Informed Consent documents according to local law and document t
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