Site monitoring and site management responsibility for clinical studies according to Company, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. Assures the implementation of project plans, as assigned.Essential Job Duties:1) 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 assigned2) Responsible for all aspects of site management as prescribed in the project plans3) General On-Site Monitoring Responsibilities:4) Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study5) Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements6) Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review7) Monitor data for missing or implausible data8) Ensure the resources of the Sponsor and Covance 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 Covance travel policy9) Ensure audit readiness at the site level10) Travel, including air travel, may be required and is an essential function of the job.11) Prepare accurate and timely trip reports12) Interact with internal work groups to evaluate needs, resources and timelines13) Act as contact for clinical trial supplies and other suppliers (vendors) as assigned14) Responsible for all aspects of registry management as prescribed in the project plans15) Undertake feasibility work when requested16) participate in and follow-up on Quality Control Visits (QC) when requested 17) 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 assigned18) Assist Senior CRA with managing investigator site budgets19) Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs20) Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management21) Assist with training, mentoring and development of new employees, e.g. co-monitoring22) Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned23) Perform other duties as assigned by managementExperienceMinimum Required:- Six (6) months experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, etc.)- 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- Works efficiently and effectively in a matrix environment- Valid Driver's LicensePreferred:- One (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- 6 months on site monitoring experienceEducationMinimum Required:- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.- Basic knowledge of Regulatory Guidelines- Basic understanding of the clinical trial process- Fluent in local office language and in English, both written and verbal Preferred:- Working knowledge of Covance SOPs regarding site monitoringFortrea is proud to be an Equal Opportunity Employer:As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.For more information about how we collect and store your personal data, please see ourPrivacy Statement.
