Fortrea's FSP team is currently seeking two CRA II professionals to join the team in Madrid. Candidates must have at least 3 - 4 years of experience working on complex clinical trials, specifically within oncology: early phases / lung phase I / immunology / Gastrointestinal - Prostate - Bladder and renal cancer.
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 specifically within oncology: early phases / lung phase I / immunology / Gastrointestinal - Prostate - Bladder and renal cancer.
- 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.