Fortrea

Design and validate patient-centered clinical measures, manage and analyze research data, prepare deliverables, and support regulatory and reimbursement strategies. | Bachelor’s or Master’s degree in social science or related field with 2-4 years research experience, strong research and writing skills, and familiarity with clinical research and regulatory guidance. | Patient-Centered Endpoints Senior Research Associate; US Remote-based Join Fortrea’s patient-centered outcomes research team and help shape the future of clinical development. As a Senior Research Associate (PACE), you will contribute to the design and validation of measures that elevate the patient voice in pharmaceutical and biotech programs. Your work will support regulatory filings, reimbursement strategies, and real-world evidence generation. Key Responsibilities Understands client requirements and participates in discussions about how the work will be completed and delivered to the client Prepares project proposals incorporating specific client requirements using standard formats Contributes to collection, management and analysis of qualitative and quantitative data using appropriate methods Evaluates the data collected and synthesizes to illustrate key points, patterns and trends. Assists in developing findings and recommendations appropriate to client requirements Prepares high quality drafts of written deliverables including tables, figures, illustrations and text Organizes materials prepared during client engagements and ensures materials are properly stored for future access Participates in internal evaluations of engagements including review of work plan, budget, client response and potential for future work And all other duties as needed or assigned Required Qualifications Master’s or bachelor’s degree in social science, public health, health services research, or related field 2–3 years (Master’s) or 3–4 years (Bachelor’s) of experience in a research setting Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience with qualitative and quantitative research methods Strong scientific writing and analytical skills Familiarity with clinical research Knowledge of regulatory guidance for patient-focused drug development Ability to manage multiple projects in a fast-paced environment Effective communicator and collaborator Preferred: located near or in Durham, North Carolina Work Environment Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations with occasional travel both domestic and international. Physical Requirements Frequently stationary for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Regular and consistent attendance. Varied hours may be required. What We Offer Opportunities to work on high-impact, patient-centered research Collaborative and inclusive team culture Employee Resource Groups (ERGs) and wellness programs Flexible remote work arrangements Pay Range: USD $85,000-$105,000 Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. Application Deadline: October 17, 2025 At Fortrea, we value diverse perspectives and inclusive research. If you're passionate about improving patient outcomes and thrive in a collaborative environment, we encourage you to apply and help us shape the future of healthcare. Learn more about our EEO & Accommodations request here. Didn’t find what you were looking for? Join our Global Talent Network to stay connected with Fortrea, drive innovation and contribute to our mission of advancing life-saving therapies for patients worldwide. Follow us and stay updated about Fortrea on LinkedIn, Facebook, X, Instagram, YouTube and Glassdoor. At Fortrea, we're all about turning the “impossible” into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.

Manage clinical study site monitoring and site management including regulatory compliance, data integrity, SAE reporting, project coordination, and training junior staff. | Requires 1+ years clinical monitoring experience, knowledge of regulatory requirements, advanced site management skills, strong communication, and ability to travel extensively. | We are currently seeking an experienced Medical Device CRA II residing in the Boston area, the East Coast or Central US. Job Overview: The CRA 2 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): • One (1) 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. Work Environment: • Work is performed in an office environment with exposure to electrical office equipment. • Frequent travel to clients/ site locations with occasional travel both domestic and international. Physical Requirements: • Ability to sit for extended periods and operate a vehicle safely. • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. • Ability to access and use a variety of computer software developed both in-house and off-the-shelf. • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. • Regular and consistent attendance. • Varied hours may be required. Target Pay Range (based on title): $100-115K Learn more about our EEO & Accommodations request here.

The Clinical Trial Administrator (CTA) is responsible for executing clinical research projects, including maintaining documentation and tracking study activities. They assist with administrative functions and ensure compliance with protocols and regulatory standards. | Candidates must have at least 1 year of clinical research experience and a diploma or equivalent. Strong communication, organizational skills, and proficiency in Microsoft Office are required. | Our FSP Team is looking to hire Clinical Trial Admins in the US! Prior clinical research experience required! Job Overview: The Clinical Trial Administrator (CTA) is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project. The degree of responsibility given to the CTA shall reflect their experience, and level of contribution which they can make to the project. The CTA performs study-related tasks as required by the department, including (but not limited to): communicate with project team members regarding study updates, maintain documentation as required by protocols, SOPs and regulatory standards, to ensure timely production of high quality clinical data, provide systems support, track information related to the status of study activities and assist with general administrative functions as required. Activities will be conducted in compliance with Company or Sponsor SOPs and regulatory standards and guidelines applicable. Summary of Responsibilities: Document and track study activities using relevant forms and tools, as well as relevant Project Management Systems with guidance/support. Assist in the preparation of study and site-specific materials in accordance with relevant SOPs. Complete minute taking and documentation for sponsor/external or internal teleconferences as requested. Assist in setting up and maintaining tracking systems/spreadsheets for e.g., study supplies. Maintain the Project Directory. Provide support for Investigator Meetings; track meeting attendees and/or other information regarding the Investigator Meeting. Provide support to project team (e.g., proof-reading and editing correspondence, mailings, shipping of study files, faxing and photocopying documents, assembling study documents, and arranging meetings, etc.). Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive as applicable. Audit and CAPA tracking. Set up and maintain clinical investigator files and documentation. Liaise with vendors, as needed, for study conduct such as printing study materials and/or external systems access for study team members. Coordinate and plan study supply shipments with vendors. Maintain and confirm shipment information such as courier tracking numbers and date of shipping and delivery. Prepare/assemble/ship supplies to sites pre-SIV: Study File Notebooks, CRFs, other study-specific ancillary supplies (i.e., diary cards, patient visit reminders). Generate reports as needed, for example CTMS site contact information list. Work with the In-House CRA and other project team members on reconciliation of data with CTMS. General communications to sponsors, sites and internal team members via electronic mail or courier or telephone. Perform other administrative duties as assigned by Line Manager, Project Managers or Clinical Trial Lead. All other duties as needed or assigned. Qualifications (Minimum Required): Diploma – Associate degree or equivalent. In lieu of the above requirement, candidates with 1-2 or more years of relevant Clinical Research experience in pharmaceutical or CRO industries may be considered. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Speaking English and local language. Writing/Reading English and local language. Experience (Minimum Required): 1+ year of experience in a clinical research setting (Clinical Trial Assistant, Study Coordinator, or similar). General knowledge of applicable clinical research principles and requirements, including GCP and ICH guidelines. Good oral and written communication skills. Good organizational and time management skills. Computer literacy (Microsoft Office Suite (Word, Excel, PowerPoint). Aptitude for handling and proof-reading numerical data, some spreadsheet software competency. Good typing skills. Good spelling and proof-reading skills. Ability to operate standard office equipment (e.g., fax, copier). Works efficiently and effectively in a matrix environment. Physical Demands/Work Environment: Office/Home-Based: Work is performed in an office environment with exposure to electrical office equipment. Physical Requirements: Frequently stationary for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Regular and consistent attendance. Varied hours may be required. Pay Range: $50,000-55,000K USD - hourly role Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, please click here. Learn more about our EEO & Accommodations request here. Didn’t find what you were looking for? Join our Global Talent Network to stay connected with Fortrea, drive innovation and contribute to our mission of advancing life-saving therapies for patients worldwide. Follow us and stay updated about Fortrea on LinkedIn, Facebook, X, Instagram, YouTube and Glassdoor. At Fortrea, we're all about turning the “impossible” into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.

Manage clinical trial administrative tasks including documentation, tracking study activities, supporting project teams, maintaining Trial Master Files, coordinating shipments, and mentoring junior staff. | 2-3 years clinical research administrative experience, strong organizational and communication skills, proficiency with Microsoft Office, leadership within CTA group, and ability to work in matrix environments. | Fortrea's FSP team is hiring Sr. CTAs! Seeking experienced Clinical Research Professionals with prior experience working for a Sponsor or within a FSP model. Oncology experience preferred. Home Based in the US. Job Overview: The Senior Clinical Trial Administrator (Sr. CTA) is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project. The degree of responsibility given to the Sr. CTA shall reflect their experience, and level of contribution which they can make to the project. The CTA performs study-related tasks as required by the department, including (but not limited to): communicate with project team members regarding study updates, maintain documentation as required by protocols, SOPs and regulatory standards, to ensure timely production of high quality clinical data, provide systems support, track information related to the status of study activities and assist with general administrative functions as required. Activities will be conducted in compliance with Company or Sponsor SOPs and regulatory standards and guidelines applicable. Summary of Responsibilities: • Document and track study activities using relevant forms and tools, as well as relevant Project Management Systems with minimal guidance and support. • Assist in the preparation of study and site-specific materials in accordance with relevant SOPs. • Complete minute taking and documentation for sponsor/external or internal teleconferences as requested. • Create and maintain tracking systems/spreadsheets for e.g., study supplies. • Maintain the Project Directory. • Provide support for Investigator Meetings; track meeting attendees and/or other information regarding the Investigator Meeting. • Provide support to project team (e.g., proof-reading and editing correspondence, large and small documents, mailings, shipment of study files, fax, and photocopy documents, assemble study documents, and arrange meetings, etc.). • Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive as applicable. Audit and CAPA tracking. • Set up and maintain clinical investigator files and documentation. • Liaise with vendors, as needed, for study conduct such as printing study materials and/or external systems access for study team members. • Coordinate and plan study supply shipments with vendors. • Maintain and confirm shipment information such as courier tracking numbers and date of shipping and delivery. • Prepare/assemble/ship supplies to sites pre-SIV: Study File Notebooks, CRFs, other study specific ancillary supplies (i.e., diary cards, patient visit reminders); 12) Generate reports as needed, for example the CTMS site contact information list. • Work with the In-House CRAs and other project team members on reconciliation of data with the CTMS. • General communications to sponsors, sites and internal team members via electronic mail or courier or telephone. • Perform other administrative duties as assigned by Line Manager, Project Managers or Clinical Trial Lead. • Train and mentor less experienced Clinical Trial Administrators. • May serve as the Lead CTA on projects where there is more than 1 CTA (provide guidance, facilitate teleconferences, task review, task delegation). • Liaise with other departments to ensure project delivery. • All other duties as needed or assigned. Qualifications (Minimum Required): • Diploma - Associate degree or equivalent. • In lieu of the above requirement, candidates with 2-3 or more years of relevant Clinical Research experience in pharmaceutical or CRO industries may be considered. • Fortrea may consider relevant and equivalent experience in lieu of educational requirements. • Language Skills Required: • Speaking: English and local language. • Writing/Reading: English and local language. Experience (Minimum Required): • Minimum two (2-3) years administrative experience or equivalent training/experience. • Good oral and written communication skills. • Proven leadership within the CTA group. • Good organizational and time management skills. • Computer literacy (Microsoft Office Suite (Word, Excel, PowerPoint). • Critical Thinking and Problem Solving. • Preferred: • Aptitude for handling and proof-reading numerical data, some spreadsheet software competency. • Good typing skills. • Good spelling and proof-reading skills. • Aptitude for handling and reviewing numerical data. • Ability to operate standard office equipment (e.g., fax, copier). • Works efficiently and effectively in a matrix environment Physical Demands/Work Environment: • General Office Environment or Home-based. • Travel Requirements: • 0-20%. Pay Range:$58,000-64,000 USD - hourly position Benefits: All job offers will bebased on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, pleaseclick here. Applications will be accepted on an ongoing basis. Learn more about our EEO & Accommodations request here.

Provide programming support for analysis of real-world data from various sources. Ensure excellence in the programming of analysis-ready datasets, tables, listings, and figures. | Bachelor’s or Master’s degree in relevant fields is required, with equivalent experience considered. A minimum of 3-5 years of RWE analysis experience in the CRO or Pharmaceutical Industry is necessary. | Senior Analyst, Real World Evidence (RWE) (Remote): This is a permanent, remote opportunity that can be worked from anywhere in U.S We are seeking a Senior Analyst, Real World Evidence (RWE) (US Remote) to provide programming and analysis support for Real World Evidence projects for Fortrea clients. Ideal candidate will have a firm understanding of the various sources on Real World Data to be used in the analysis. Summary of Responsibilities: Provide programming support for analysis of real-world data from different sources including medical and pharmacy claims data, hospital data, electronic medical record data, and prospective observational study data. Contribute to development of programming specifications for conducting the analysis using requirement details and source data. Develop/validate analysis datasets from a variety of file and formats from either internal or external vendors as well as using diverse collection of data files in terms of the type, data format and size. Develop/validate graphs and tables primarily for exploratory investigations with analysis requirements that may change throughout the life of the project. Ensure excellence in the programming of analysis ready datasets, tables, listings, and figures, and associated validation work. Communicate accurate and timely status updates to project lead and other project team members. Identify processes within programming that will increase productivity, quality, and efficiency. All other duties as needed or assigned. Qualifications (Minimum Required): Bachelor’s or Master’s degree in Computers, Engineering, Statistics, Health Informatics, Life Sciences, Mathematics, Economics, or Econometrics. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required): Typically, 3-5 years of RWE analysis experience in the CRO or Pharmaceutical Industry, or an equivalent combination of education and experience to successfully perform the key responsibilities of the Job. Experience in handling data from EHR/Claims databases (Optum, Marketscan, Flatiron etc.) is required. Proficiency in SAS and SQL programming. Pay Range: USD $80,000-95,000 annually Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. Application Deadline: August 29,2025 #LI-SE1 #LI-Remote Learn more about our EEO & Accommodations request here. Didn’t find what you were looking for? Join our Global Talent Network to stay connected with Fortrea, drive innovation and contribute to our mission of advancing life-saving therapies for patients worldwide. Follow us and stay updated about Fortrea on LinkedIn, Facebook, X, Instagram, YouTube and Glassdoor. At Fortrea, we're all about turning the “impossible” into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.