{"id":2547198,"url":"https://alion.io/job/fortrea-sr-cra-i-2","title":"SR CRA I","company":{"id":3171,"name":"Fortrea","domain":"fortrea.com","url":"https://alion.io/company/fortrea","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Administrative","role_family":"Administrative","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Mexico City, Mexico"],"countries":["MX"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":28000,"max_usd":67000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":2188},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-14T17:08:36Z","employer_posted_date":"2026-10-14","last_verified_at":"2026-10-20T08:12:03Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"description":"Job Overview:\nThe Senior CRA I is responsible for site monitoring and site management. Responsibility for clinical studies according to Fortrea, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. The Senior CRA I assure the implementation of project plans, as assigned. Function as leader for projects of limited scope, as assigned. Assume line management responsibilities, as assigned. Act in the project role of a Local Project Coordinator or Lead CRA as assigned.\nSummary of Responsibilities:\nThe statements below are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties.\nResponsible 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.\nResponsible for all aspects of site management as prescribed in the project plans.\nGeneral On-Site Monitoring Responsibilities:Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.\nEnsure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.\nEnsure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.\nMonitor data for missing or implausible data.\nEnsure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.\nEnsure audit readiness at the site level.\nTravel, including air travel, may be required and is an essential function of the job.\nPrepare accurate and timely trip reports.\nManage small projects under the direction of a Project Manager/Director as assigned.\nServe as lead monitor for a protocol or project and may assist in establishing monitoring plans and trip report review as assigned.\nReview progress of projects and initiate appropriate actions to achieve target objectives.\nOrganize and make presentations at Investigator Meetings.\nParticipate in the development of protocols and Case Report Forms as assigned.\nParticipate in writing clinical trial reports as assigned.\nInteract with internal work groups to evaluate needs, resources, and timelines.\nAct as contact for clinical trial supplies and other suppliers (vendors) as assigned.\nResponsible for all aspects of registry management as prescribed in the project plans.\nUndertake feasibility work when requested.\nConduct, report, and follow-up on Quality Control (QC) visits when requested.\nRecruitment 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.\nNegotiate study budgets with potential investigators and assist the Fortrea legal department with statements of agreements as assigned.\nTrack and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.\nIndependently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management.\nAssist with training, mentoring and development of new employees, e.g., co-monitoring.\nCoordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned 29) Perform other duties as assigned by management.\nAll other duties as needed or assigned.\nQualifications (Minimum Required):\nUniversity or college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.\nIn lieu of the above education requirement, candidates with a minimum of 3 years relevant clinical research experience in pharmaceutical or CRO industries will be considered.\nThorough knowledge of regulatory requirements including a basic understanding of regulatory requirements in other countries.\nThorough understanding of the drug development process.\nFluent in local office language and in English, both written and verbal.\nFortrea may consider relevant and equivalent experience in lieu of educational requirements.\nExperience (Minimum Required):\nThree (3) years of Clinical Monitoring experience.\nHave a full understanding of Serious Adverse Event (SAE) reporting, process production on reports, narratives and follow up of SAEs.\nAdvanced site monitoring skills.\nAdvanced study site management skills.\nAdvanced registry administration skills.\nAbility to work with minimal supervision.\nGood planning and organization skills.\nGood computer skills with good working knowledge of a range of computer packages.\nAdvanced verbal and written communication skills.\nAbility to train and supervise junior staff.\nAbility to resolve project-related problems and prioritizes workload for self and team.\nAbility to work within a project team.\nWorks efficiently and effectively in a matrix environment.\nValid Driver's License.\nPreferred Qualifications Include:\nOne (1) or more year's additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.\nLocal project coordination and/or project management experience.\nPhysical Demands/Work Environment:\nTravel requirements: 60-80% overnight.\nLearn more about our EEO & Accommodations request here.","description_format":"text","description_chars":5889,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All 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