About this role
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 Immunology / Hypertension.
Summary of Responsibilities:
• 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. • Responsible for all aspects of site management as prescribed in the project plans. • Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study. • Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. • Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. • Monitor data for missing or implausible data. • Ensure audit readiness at the site level. • Travel, including air travel, may be required and is an essential function of the job. • Prepare accurate and timely trip reports. • Interact with internal work groups to evaluate needs, resources, and timelines. • Act as contact for clinical trial supplies and other suppliers (vendors) as assigned. • Responsible for all aspects of registry management as prescribed in the project plans. • Undertake feasibility work when requested. • Participate in and follow-up on Quality Control Visits (QC) when requested. • 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. • Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs. • 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):
• University Degree in Scientific / Medical Field • Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements in Spain • Fluent in Spanish and in English, both written and verbal.
Experience (Minimum Required):
• Minimum 3 -4 years of experience as independent monitor, working in Immunology / Hypertension Clinical Studies. • Basic understanding of Regulatory Guidelines. • Ability to work within a project team. • Good planning, organization, and problem-solving skills. • Good computer skills with good working knowledge of a range of computer packages. • Valid Driver's License
Learn more about our EEO & Accommodations request here.