Clinical Research Associate II- Barcelona
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:
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 Onco - Hematology or Gynecologic Oncology 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
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