Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry.
We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need.
Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services.
Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network.
Our talented and diverse team of approximately 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally.
Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.

Fortrea

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navigator

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. 

Our talented and diverse team of approximately 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.

• Coordinate site-level activities throughout clinical study start-up and potentially closeout
• Serve as the primary point of contact for investigative sites
• Identify and assess potential research sites
• Conduct initial site outreach and collect confidentiality agreements and feasibility surveys
• Manage remote pre-study visits and follow-up documentation
• Support customization and translation of informed consent forms and patient-facing materials
• Collect, track, and quality-review essential documents required for site activation
• Maintain site regulatory compliance and support IRB/IEC renewals, PI changes, and document expirations
• Participate in study team meetings and develop action plans for site-level risks and issues
• Support CRA teams with site initiation visit preparation and coordination of supplies, access, and documents
• Submit to and liaise with IRB/IEC, Third Bodies, and Regulatory Authorities
• Conduct initial and amended contract and budget negotiations with research sites
• Maintain audit-ready filing systems and update the Trial Master File
• Track start-up progress and ensure sites meet requirements and deadlines
• Serve as primary contact for investigative sites and ensure timely delivery within scope and budget
• Perform CRF review and source-data validation, and monitor protocol deviations and SAE reporting
• Perform country and site informed-consent-form review and customization
• Complete other assigned duties throughout the study

Site Navigator I, II

Site Navigator coordinating clinical-trial site activation for Fortrea, a clinical research organization advancing life-saving therapies. Managing regulatory documents, site relationships, contracts, and study-startup milestones.

associate

• Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial.
• Triage of incoming cases to prioritize for daily workflow management.
• Perform medical adjudication for event validity/seriousness/expectedness/listedness/causality using the WHO-UMC system in coordination with the medical review team.
• Data entry of safety data onto adverse event database(s) and tracking systems.
• Review of adverse events for completeness, accuracy and appropriateness for expedited reporting.
• Write patient narratives, code adverse events accurately using MedDRA and determine listedness against appropriate label.
• Identify clinically significant information missing from the reports and ensure its collection and follow-up.
• Ensure all cases that requiring expediting reporting to worldwide Regulatory Agencies and other required parties are processed swiftly and appropriately within required timelines.
• Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
• Support root cause analysis and CAPA plan development & implementation for identified quality issues as needed.
• Support and/or participate in audits and inspections including the preparation as needed.
• Demonstrate role-specific Core Competencies and company values on a consistent basis.
• Build and maintain good PSS relationships across functional units.
• Undertake any other duties as needed.

Associate II, Patient Safety Solutions

Remote Associate II in Patient Safety Solutions at Fortrea managing clinical trial adverse events reporting and processing. Requires strong clinical knowledge and understanding of the US Healthcare system.

general

• Drive rapid, accurate, and data-driven study start up forecasts
• Develop creative processes, methodologies for Study Start Up Services
• Partner with Clinical Operations teams to improve study start up metrics
• Guide the collection and analysis of all data to influence start up timelines

Lead Start Up Specialist, FSP

Lead Study Start Up Specialist developing methodologies to deliver study start up services for patients worldwide. Collaborating with teams to improve study start up metrics and processes.

french

• 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
• 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 monitoring
• Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested
• Complete 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 of new employees, eg. 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

CRA 1/2, Sr. CRA – Oncology, General Medicine, French Speaking

CRA position responsible for site monitoring in clinical trials, supporting various sponsors with a focus on oncology and general medicine. Fluency in French is desired, with travel across Canada.

project-manager

• Oversee conduct by project lead of all aspects of contracted adjudication start-up activities for assigned project(s)
• Compiling adjudication committee membership, developing the Adjudication Committee Charter, developing the Site Manual, developing the Adjudication Services Operational Plan, Developing workflows and data capture forms and developing tracking tools and reports.
• Developing and delivering project-specific training to stakeholder groups (e.g., Adjudication Services staff, project team members, client staff, adjudicators, sites).
• Provide ongoing functional operational oversight of the project lead who is directly responsible for the Adjudication Services scope for assigned project(s).
• Providing oversight of Adjudication Services team activities pertaining to: deliverables, procedures, timelines, scope of work, budget, quality, productivity and profitability.
• Monitoring workflow and project status to ensure all deliverables and deadlines are met; making adjustments and escalating potential issues to relevant individuals, as appropriate.
• Managing any vendors contracted to support Adjudication Services.
• Reviewing and distributing event adjudication status reports and metrics to relevant stakeholders.
• Providing input into client invoicing and vendor payment.
• Serving as central point of contact and communications, representing Adjudication Services on assigned project(s).
• Interfacing regularly with customers, both internal and external (including adjudicators).
• Conducting and minuting Adjudication Services team meetings.
• Coordinating, conducting and minuting relevant sessions of adjudication meetings.
• Ensuring compliance with project budget, actively identifying out of scope work and escalating potential scope changes to appropriate individuals.
• Ensure that project leads and team members operate in accordance with the Adjudication Services Operational Plan in place on assigned project(s).
• Oversee execution of all aspects of the workflow pertaining to the processing of events for adjudication on assigned project(s).
• Maintaining event tracking systems.
• Event case processing: intake and triage, event linking, event de-activation, tracking, data entry, document processing (e.g. redaction of specified content), review of incoming event information for completeness and accuracy, content review, identification of missing required data and/or documents, generation of queries, Query review and closure/re-issue.
• Ability to direct, manage, and coordinate the day-to-day efforts of multiple levels of staff.
• Ability to work independently in a high visibility team leadership capacity, which includes effectively balancing multiple concurrent priorities in a fast-paced, complex setting.

Adjudication Project Manager

Adjudication Project Manager leading and overseeing adjudication processes and teams for clinical trials in Canada. Managing client relations and ensuring compliance with project budgets and timelines.

Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team of approximately 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.

Fortrea

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5 jobs found

Site Navigator I, II

Fortrea

Associate II, Patient Safety Solutions

Fortrea

Lead Start Up Specialist, FSP

Fortrea

CRA 1/2, Sr. CRA – Oncology, General Medicine, French Speaking

Fortrea

Adjudication Project Manager

Fortrea