FSPx SCRA

Essential Job duties:

The below statement 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. Responsible for all aspects of study site monitoring including routine monitoring and close-out 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 projects plans General on-site monitoring responsibilities Ensure the study staff who will conduct the protocol have received the proper material and instructions to safety 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 the resources of the Sponsor and Labcorp Drug Development 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 Labcorp Drug Development travel policy 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 Manage small projects under direction of Project Manager/Director as assigned Serve as lead monitor for a protocol or project, and may assist in establishing monitoring plans and trip report review as assigned Review progress of projects and initiate appropriate actions to achieve target objectives Organize and make presentations at Investigator Meetings Participate in the development of protocols and Case Report Forms as assigned Participate in writing clinical trial reports as assigned 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 Conduct, report and follow-up on Quality Control Visit(QC) when requested Recruitment of potential investigators, preparation of EC submissions, notification to regulatory authorities, translation of study related documentation, organization of meetings and other tasks as instructed by supervisor Negotiate study budgets with potential investigators and assist the Labcorp Drug Development legal department with statements of agreements as assigned 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 Labcorp Drug Development or client data management systems as assigned by management  Assist with training, mentoring and development of new employees, e.g. co-monitoring  Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned  Perform other duties as assigned by management

Experience Minimum required:

Two (2) years of clinical monitoring experience Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs Advanced site monitoring skills Advanced study site management skills Advanced registry administration skills Ability to work with minimal supervision Good planning and organization skills Good computer skills with good working knowledge of a range of computer packages Advanced verbal and written communication skills Ability to train and supervise junior staff Ability to resolve project-related problems and prioritizes workload for self and team Ability to work within a project team Works efficiently and effectively in a matrix environment Valid Driver’s License

Education/Qualifications/Certifications and Licenses

Minimum Required:

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). In lieu of the above education requirement, candidates within a minimum of 6 years recent clinical monitoring experience will be considered Thorough knowledge of regulatory requirements Thorough understanding of the drug development process Fluent in local office language and in English, both written and verbal Or an equivalent combination of education and experience to successfully perform the key responsibilities of the job

Fortrea 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.

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