Ref #: 26996

Employment type: Permanent - Full-Time

Location: Spain

Posted: 18-Feb-2021

Description

Role & Responsibilities:
Responsible for the support and management of study sites for Phase I-IV clinical studies according to SOP’s, GCP regulations and protocol requirements.
Identify, evaluate and recommend potential study sites for participation based on feasibility
Perform pre-trial assessment visits and coordinate site initiation visits
Assures that site personnel complete and document protocol-specific training
Conducts on-going study visits and perform Monitoring visits on a routine basis
Performs source documentation as required by SOP to ensure protocol/patient compliance
Reports any site issues to Clinical Team
Ensures that Trial Centre File (TCF) is current up to date
Performs drug accountability and any re-labelling that may be required
Responds to site questions and escalates as necessary for resolution
Attends investigator meetings
Participate in QA or FDA audits when necessary

What is Required:
Education: BSN/BS/MS or BA required
Experience: a minimum of two years independent monitoring experience
TA: All TA, Oncology highly valued and Phases I
Knowledge of Microsoft Office applications especially Excel
English: Fluent spoken & written
Good interpersonal skills demonstrated as proactive, enthusiastic, and independent thinker
Ability to collaborate and build strong relationships with all functions involved in the trial
Works and meets deadlines with some supervision
Must be able to travel in accordance with company and project requirements

What is Offered:
We offer a permanent contract, full time role based in Madrid
We offer an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a company dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life.

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