Clinical Research Associate II- Barcelona
Description
Fortrea's FSP team is currently seeking two CRA2 professionals to join the team in Barcelona. Candidates must have at least 3 - 4 years of experience working on complex clinical trials, specifically within Gynecologic Oncology or Onco - Hematology .
Summary of Responsibilities
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Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.
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Responsible for all aspects of site management as prescribed in the project plans.
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Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
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Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
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Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
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Monitor data for missing or implausible data.
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Ensure audit readiness at the site level.
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Travel, including air travel, may be required and is an essential function of the job.
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Prepare accurate and timely trip reports.
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Interact with internal work groups to evaluate needs, resources, and timelines.
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Act as contact for clinical trial supplies and other suppliers (vendors) as assigned.
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Responsible for all aspects of registry management as prescribed in the project plans.
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Undertake feasibility work when requested.
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Participate in and follow-up on Quality Control Visits (QC) when requested.
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Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned 18) Assist Senior CRA with managing investigator site budgets.
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Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
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Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management.
Qualifications (Minimum Required)
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University Degree in Scientific / Medical Field
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Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements in Spain
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Fluent in Spanish and in English, both written and verbal.
Experience (Minimum Required)
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Minimum 3 -4 years of experience as independent monitor, working in Onco - Hematology or Gynecologic Oncology Clinical Studies.
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B asic understanding of Regulatory Guidelines.
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Ability to work within a project team.
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Good planning, organization, and problem-solving skills.
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Good computer skills with good working knowledge of a range of computer packages.
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Valid Driver's License
Learn more about our EEO & Accommodations request here .