Senior Clinical Research Associate

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 Senior Clinical Research Associate in Portugal.
About this role: As part of our Clinical Operations team, you will work alongside passionate and innovative professionals to ensure our customers achieve their goals.
The Senior Clinical Research Associate is responsible for the initiation, on-site and remote monitoring, and termination of investigative sites during study conduct, according to company policies, SOPs, and regulatory requirements.
The Senior Clinical Research Associate may assist the Project Manager in certain aspects of project activities which may include project tracking, monitoring plans, review of monitoring reports, and CRA resources management. The Senior Clinical Research Associate may also conduct all stages of site monitoring (feasibility, pre-study, initiation, interim, and close-out). Ability to travel as needed; may involve overnight and international travel.

Key Responsibilities:
Monitor on-site and remotely clinical trials in accordance with TFS and/or client company Standard Operating Procedures, FDA regulations, and GCP and ICH guidelines.
Review CRFs (paper or electronic) and subject source documentation for validity and accuracy and generate queries to investigational sites/clients to resolve problem data.
Identify site problems/deficiencies and bring to the attention of management through trip reporting, memos, and verbal communication with Project Manager or Lead CRA.
Initiate corrective action to resolve issues as directed by supervisor.
Contribute to the completion of the application to Ethics Committee/IRB, prepare necessary documentation enclosed to the application according to local requirements in cooperation with CTA and directed by Lead CRA/Project Manager.
Participate in contract handling and negotiation directed by Lead CRA/Project Manager.
Set up ISF and SMF (or cooperate with CTA) and distribute to the investigational sites.

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