Job Overview 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. 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.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.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.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. Qualifications (Minimum 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.Fortrea may consider relevant and equivalent experience in lieu of educational requirements.Basic knowledge of Regulatory Guidelines.Basic understanding of the clinical trial process.Fluent in local office language and in English, both written and verbal. Experience (Minimum 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 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.6 months on site monitoring experience.Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors.Demonstrated ability to conduct clinical operations activities most effectively and efficiently.Attention to detail.Methodical approach to work.Understanding of medical and clinical research terminology and clinical research processes.An understanding of the basics of physiology, pharmacology, and medical devices (when applicable).Understanding of the principles of ICH GCP, ISO 14155 (if applicable) and regulatory requirements.Good computer literacy with working knowledge of PCs, Windows, and Microsoft Office applications.Good oral and written internal and external communication. Strong interpersonal team and organizational skills, personal presentation. The ability to communicate effectively in English.Experience using a clinical trial management system (CTMS).For medical device positions, experience in providing customer service to device end users. Learn more about our EEO & Accommodations request here.

Se busca un Especialista en Iniciación de Estudios Clínicos para gestionar la recopilación de documentos y asegurar el cumplimiento normativo en diversas entidades. El candidato actuará como punto de contacto principal, guiando al equipo en los procesos de activación de sitios y monitoreando el cumplimiento a tiempo.

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.

Job Overview Primary contact with investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study, to ensure EC/IRB/Third body/Regulatory Authority and any other local applications are made within the timelines agreed with project management and Site Readiness team and that documentation meets the specifications required by applicable regulations and sponsor. Proactively interacts with EC/IRB/Third body/Regulatory Authorities to provide guidance regarding requirements. Maintain awareness of current regulatory standards related to submissions. Serve as local expert in project start-up activities for a particular country or region. Act as a ‘knowledge resource’ to mentor and train new hires and less-experienced department colleagues if suitable. Summary Of Responsibilities Maintain awareness of regulatory legislation, guidance, and practice in the assigned countries.Coordinate, collect and organize data and information required by EC/IRB/Third body/Regulatory Authority including but not limited to the preparation of study documentation such as the country application form and cover letter for sponsor review as applicable.Compile and prepare routine submission filed to IRB/IEC/Third body/Regulatory Authorities (e.g., INDs/CTAs) and liaise with them as applicable regarding submission/approval.Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable).Perform a review of final submission documents as applicable.Ensure that all assigned start-up and maintenance activities are on track, in accordance with client expectations and budget and in compliance with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs and quality standardsPrevent and escalate study issues appropriately and in a timely fashion.Perform other duties as assigned by management depending upon country and situational requirements with proper supervision [if applicable].In Country specific tasks (Global):Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.Collect and track all the necessary documents required and perform a quality review, formatting, and compilation of the final documents for effective and compliant site activation and maintenance without supervision.Ensure high quality documents are filed and systems are updated on an ongoing and timely basis, making Fortrea ready for an audit at any time.Participate in team and project meetings as applicable.When needed, assist in the strategy definition for Site Activation and provide accurate projections and timelines to study teams.Review and customize country and site-specific patient informed consent forms for compliance with local requirements and protocol. Proactively resolve informed consent issues and other potential difficulties with study sites.May support the negotiation of site contracts and budgets with sites, if applicable and track progress of contract and budget milestones/developments, intervening and escalating as appropriate.Proactively identifying and escalating to Submission Leads any risk to meeting deliverables.Notify the Submissions Lead of hours identified as Out-of-Scope or overburn.Clinical Trials Information System (CTIS) tasks (specific centralized role for EU):Assist in the upload of submission documentation to, interacting with and monitoring of all notifications and alerts in CTIS to ensure all milestones and events for the trial are met within the timelines mandated.Performs all other duties as needed or assigned. Qualifications (Minimum Required) University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations.Fortrea may consider relevant and equivalent experience in lieu of educational requirements.In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations will be considered. Experience (Minimum Required) Minimum of 2 years of experience in clinical development or start-up/ regulatory process.Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites.Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them. Physical Demands/Work Environment General Office Environment. Learn more about our EEO & Accommodations request here.