Job Overview: The 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. Summary of Responsibilities: - The 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. - 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. - General 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. - 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 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. - 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 the direction of a 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 (QC) visits 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. - Negotiate study budgets with potential investigators and assist the Fortrea 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 Fortrea 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 29) Perform other duties as assigned by management. - All other duties as needed or assigned. Qualifications (Minimum Required): - University 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. - In 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. - Thorough knowledge of regulatory requirements including a basic understanding of regulatory requirements in other countries. - Thorough understanding of the drug development process. - Fluent in local office language and in English, both written and verbal. - Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required): - Three (3) years of Clinical Monitoring experience. - Have a full understanding of Serious Adverse Event (SAE) reporting, process production on 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. Preferred Qualifications Include: - 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. - Local project coordination and/or project management experience. Physical Demands/Work Environment: - Travel requirements: 60-80% overnight. Learn more about our EEO & Accommodations request here.

• Establish scope and detailed requirements for the project. Includes facilitating requirements gathering sessions with key stakeholders, documenting the requirements, and managing the requirements through the life of the project. • Identify and manage issues, risks and changes. • Communicate and follow-up regularly with team members to ensure tasks are completed according to plans. • Develop project plans for schedule, resources, and budget. Requires collaboration with resources managers, lead team members, Finance, and executives. • Monitor and track progress against plans. • Report status to project stakeholders through multiple formal communication methods (e.g, monthly status reports, bi-weekly snapshot reports, project plan updates) and informal methods (e.g, ad-hoc requests and email). • Communicate effectively with project team members, management, and project stakeholders on status, issues, risks, and project goals and objectives. • Create status reports on a regular basis. • Actively engage in continuous improvement of the organization's project management processes and standards. • Monitor actual project hours and costs against the project/program estimates and budget. • Monitor and report on the project budget. • Other duties as required.

• Assist with the development and administration of RDT&E contracts, including tasks such as the development of solicitation material, administration of source selection reviews, and assessing technical solutions. • Monitor project performance and review deliverables to ensure technical, programmatic, and financial goals and objectives are met and identify possible program risks. • Maintain and monitor program budgets to include gathering and reviewing monthly reporting information from project/program performers and developing budget execution plans. • Organize, direct, and coordinate planning and production of all activities associated with assigned task order projects. • Provide support to Portfolio and Program Managers in their continued engagement with DHS S&T customers on the receipt, prioritization, and regular reporting of their operational capability gaps. • Provide data collection and analyses of user requirements and of existing and emerging systems, capabilities, and technologies. • Perform routine tasks including, but not limited to, scheduling, writing internal memos, maintaining, and updating Program Management records, filing, intranet website maintenance, preparing and reviewing presentations, records maintenance, and coordinating daily operations of the assigned program. • Assist with planning technology transitions to the respective operational customer. • Attend meetings, workshops, conferences, and program reviews at the direction of the program or project manager to provide a programmatic and technical review, record meeting minutes, and contribute to the program management dialogue with performers. • Provide assistance in managing and responding to program-aligned S&T Executive Secretary data calls, compiling information, and preparing information for reporting to senior leadership. • Support the identification, assessment, evaluation, and testing of existing and emerging technologies, systems, and capabilities, including coordination with related government, academic, and industry programs; attending meetings and symposia; coordinating meetings and programs reviews, and supporting program advocacy including development and production of presentation materials.

• Manage multiple website development projects simultaneously • Ensure projects are moving according to workflow • Communicate with clients, designers, copywriters, and programmers