São Paulo, São Paulo, Brazil · Remote OK
Job Overview: Site Navigators II plays a critical role in the comprehensive coordination of site-level activities throughout the start-up phase of a clinical study and potentially through closeout activities as required.…
Skills: Site Management, Regulatory Compliance, ICH/GCP Guidelines, Clinical Study Start-up, Contract Negotiation
Bengaluru, Karnataka, India · Hybrid
Summary of Responsibilities: Lead complex studies such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations, providing statistical oversight, and attending…
Skills: Biostatistics, SAS, Statistical Analysis Plans, NDA Submissions, Sample Size Calculation
Helsinki, Uusimaa, Finland · Remote OK
We are currently looking for a Clinical Research Associate based in the Helsinki area with at least 2 years of independent monitoring experience and a willingness to work across multiple sponsors. This is a great opportu…
Skills: Clinical Monitoring, ICH GCP Guidelines, Site Management, Source Data Verification, eCRF Review
Sydney, New South Wales, Australia · Hybrid
Job Overview: In the role you will collaborate with key stakeholders across the organization and at times be client facing to achieve client-centric delivery in a matrix organization. Oversight and accountability of Regu…
Skills: Regulatory Submissions, Clinical Trial Regulatory Affairs, Submission Strategy, Quality Control, APAC Regulatory Requirements
Beijing, Beijing, China · On-site
Job Overview: Collaborate with peers across the organization to achieve client-centric delivery in a matrix organization. Collaboration across all stakeholders within Site Readiness. Oversight and accountability of Regul…
Skills: Regulatory Submissions, Submission Strategy, Project Management, Compliance, Quality Control
São Paulo, São Paulo, Brazil · Remote OK
Job Overview: Our FSO team is seeking an Oncology Clinical Project Manager II or Sr Project Manager to join our growing team. This role requires 3+ years of global project management experience, with mandatory experience…
Skills: Clinical Project Management, Oncology, Budget Management, Risk Management, Stakeholder Management
São Paulo, São Paulo, Brazil · Remote OK
Job Overview: Our FSO team is seeking an Ophthalmology Clinical Project Manager II or Sr Project Manager to join our growing team. This role requires 3+ years of global project management experience, with mandatory exper…
Skills: Clinical Project Management, Ophthalmology, Budget Management, Risk Management, Stakeholder Management
São Paulo, São Paulo, Brazil · Remote OK
Job Overview: Our FSO team is seeking a General Medicine Clinical Project Manager II or Sr Project Manager to join our growing team. This role requires 3+ years of global project management experience, with mandatory exp…
Skills: Clinical Project Management, General Medicine, Budget Management, Risk Management, Stakeholder Management
Bengaluru, Karnataka, India · On-site
Job Overview: Manages ARC review and are responsible for performing TMF review of electronic Trial Master Files (eTMF), Trial, Country, and Site artifacts for clinical studies in support of sponsors services contracts an…
Skills: TMF Review, eTMF Management, GCP Guidelines, ICH Guidelines, Audit Readiness
Budapest, Central Hungary, Hungary · On-site
Be the connection between science and solutions. In this CRA position, you’ll help transform complex clinical protocols into real-world results, working alongside a team that values precision, integrity, and progress. Th…
Skills: Site Monitoring, ICH-GCP, Source Data Verification, eCRF Review, eTMF Management
Buenos Aires, Argentina · Hybrid
Job Overview: Senior Site Navigators play a critical role in the comprehensive coordination of site-level activities throughout the start-up phase of a clinical study and potentially through closeout activities as requir…
Skills: Site Activation, ICH/GCP Guidelines, Regulatory Compliance, Site Management, Contract Negotiation
São Paulo, São Paulo, Brazil · Remote OK
Job Overview: Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process, which may include safety data collected from clinical trials and/or post m…
Skills: Case Intake, Triage, Data Entry, Patient Narratives, MedDRA Coding
Buenos Aires, Argentina · On-site
Job Overview: The Clinical and Ancillary Supplies Services (CASS) Specialist II: Independently support the delivery of the Clinical and Ancillary supplies component of assigned studies within a region or for a simple glo…
Skills: Clinical Logistics, Supply Chain Management, ICH-GCP Guidelines, FDA Regulations, GMP Regulations
Hangzhou City, Zhejiang, China · Hybrid
Summary of Responsibilities: Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including veri…
Skills: Site Monitoring, ICH GCP Guidelines, Clinical Trial Management, Source Data Verification, eCRF Review
Bengaluru, Karnataka, India · Remote OK
Job Overview: Assist in the development and implementation of solutions to DM service issues and concerns regarding Medidata RAVE, Oracle Inform, CRF Design, and Data Capture or imaging activities, including proactive pr…
Skills: Python, SQL, SAS Programming, Medidata Rave, Oracle Inform
Durham, California, United States · Remote OK
$45k–$50k/yr
Job Overview: The Inside Sales Associate role within Fortrea Consulting is responsible for generating business opportunity leads that achieve quarterly and annual goals, managing inbound client interactions, and supporti…
Skills: Lead Generation, Client Relationship Management, Salesforce, Social Selling, Market Research
Daytona Beach, Florida, United States · On-site
***Experience in phlebotomy/specimen collection are required for this role*** As one of the largest Clinical Research Organizations in the world, we have four Early Phase Clinical Research Units in the UK and US. We are …
Skills: Phlebotomy, Specimen Collection, Venipuncture, ECG Recording, Holter Monitoring
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Coordinates site-level activities during the start-up phase of clinical studies, serving as the primary contact for investigative sites. Ensures regulatory compliance, manages site activation, and handles contract and budget negotiations.
Requires a university degree in life sciences or equivalent clinical research experience, with at least 2 years in clinical development or start-up processes. Must be fluent in English and the local official language with strong knowledge of ICH/GCP guidelines.
Job Overview:
Site Navigators II plays a critical role in the comprehensive coordination of site-level activities throughout the start-up phase of a clinical study and potentially through closeout activities as required. Serving as the single point of contact for investigative sites, this role ensures smooth progression from feasibility and initial outreach through to site activation, extending through the maintenance phase of the study as required. A crucial component in meeting the requirements of the Site Navigator II role is ensuring regulatory compliance, robust site management, optimal site support and training, and effective collaboration between the sponsor, CRO, and clinical site staff. This role serves as a local expert in project start-up/clinical activities for a particular country or region, performs work with limited oversight, and acts as a ‘knowledge resource’ to mentor and train junior colleagues if suitable.
Summary of Responsibilities:
Oversight of site level tasks associated with efficient site activation in accordance with ICH/GCP guidelines, local regulations, SOPs and project requirements, including collaboration with project leadership and local monitors to collaboratively achieve project milestones while also ensuring patient rights, wellbeing and safety are protected
Identifying potential research sites that align with the study's criteria and assessing their capabilities and resources.
Conduct initial site outreach, i.e., site engagement, collection of Confidentiality Agreement, and feasibility survey
Remote Pre-Study Visits and follow up documentation, including visit preparation, trip report completion, and other documentation as required to support site selection in line with sponsor, protocol, local and country regulations and requirements
Support customization and translation of informed consent forms and patient-facing materials.
Collect, track and perform a quality review of all essential documents required for effective and compliant study site activation from Site outreach, submissions, greenlight and until site activation. Maintenance and ongoing awareness of site regulatory compliance, supporting IRB/Independent Ethics Committee (IEC) annual renewals, PI change-over, and document expirations will be performed as applicable in accordance with local requirements.
Actively participate in team meetings to facilitate study progress and implement action plans for site level risks, underperforming sites, or issues impacting project milestones and escalate issues in a timely manner
Support the CRA team in preparing for site initiation visits (SIVs) by coordinating with vendors, supplies teams, and study leads to ensure timely distribution of clinical study supplies, accesses and documents per study team guidance.
Responsible for submissions to and liaise with applicable IRB/IEC, Third Bodies (if applicable), and Regulatory Authorities by collaborating with Global Regulatory Submissions Lead (GRSL)
Perform initial contract and budget negotiations with the sites, as well as amended where applicable
Ensure high quality documents are filed in applicable systems in accordance with SOPs and project requirements and that the Trial Master File (TMF) is updated and audit ready at all times.
Track the progress of the start-up process and ensure that the research site meets all requirements and deadlines.
Ensure Fortrea is audit ready by completing accurate, timely, and consistent system compliance on an ongoing basis
Serve as primary contact for investigative sites and ensure timely delivery in alignment with scope of work/study budget
Perform Case Report Form (CRF) review and data validation against source documentation according to protocol and guidelines as applicable in combination with monitoring for site protocol deviations, Serious Adverse Event (SAE) reporting, and all other duties as needed or assigned throughout the course of the study.
Perform country and site ICF review/customization, per local requirements
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) or 3+ years' work experience in clinical research, including a strong working knowledge of the ICH/GCP 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 5 years' work experience in clinical research, including a strong working knowledge of the ICH/GCP guidelines and RA, IRB/IEC regulations will be considered.
Fluent in local official language and in English, both written and verbal.
Experience (Minimum Required):
A scientific degree and/ or clinical expertise is optimal for this role.
Minimum of 2 +year of experience in clinical development or start-up/ regulatory process.
Working knowledge of ICH/GCP, 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 and educate others about them.
Effective communication with various stakeholders, including site staff, CRO personnel, and regulatory authorities.
Ability to manage multiple tasks and deadlines simultaneously, ensuring that all requirements are met in a timely manner.
Understanding of relevant regulations and guidelines related to clinical trials and research.
Ability to identify and resolve potential issues that may arise during the start-up process.
Ability to negotiate contracts and budgets effectively with research sites.
Employees will leverage their existing experience and skills to assume additional responsibilities within the broader role. These will be aligned with operational requirements and internal training, without altering the fundamental nature or classification of the position.
Physical Demands / Work Environment:
Remote-based work required with possible office presence depending on location
Travel requirements: Limited for training only
Learn more about our EEO & Accommodations request here.
Bringing life-changing benefits to patients faster
Fortrea (Nasdaq: FTRE) is a leading global clinical research organization (CRO) dedicated to providing innovative clinical development solutions to the life sciences industry. With over 30 years of clinical research experience, Fortrea has evolved from Covance and Labcorp into a pureplay CRO built for biotech, biopharma, medical device and diagnostic innovators. Fortrea collaborates with both emerging and established companies to deliver agile, fit-for-purpose full service (FSO), functional service (FSP) and hybrid solutions. Fortrea provides comprehensive Phase I-IV clinical trial management, clinical pharmacology, and consulting services, backed by deep experience in more than 20 therapeutic areas. Operating in approximately 100 countries, our diverse and talented team brings scientific rigor, operational excellence, and a strong investigator site network to every trial. By combining the best of our legacy experience with forward-thinking innovation, Fortrea brings predictability to clinical trial execution and helps transform aspirations into outcomes. Together, exceptional is possible. Learn more at Fortrea.com
Offices: Research Triangle Park, NC, US
Bringing life-changing benefits to patients faster
Fortrea (Nasdaq: FTRE) is a leading global clinical research organization (CRO) dedicated to providing innovative clinical development solutions to the life sciences industry. With over 30 years of clinical research experience, Fortrea has evolved from Covance and Labcorp into a pureplay CRO built for biotech, biopharma, medical device and diagnostic innovators. Fortrea collaborates with both emerging and established companies to deliver agile, fit-for-purpose full service (FSO), functional service (FSP) and hybrid solutions. Fortrea provides comprehensive Phase I-IV clinical trial management, clinical pharmacology, and consulting services, backed by deep experience in more than 20 therapeutic areas. Operating in approximately 100 countries, our diverse and talented team brings scientific rigor, operational excellence, and a strong investigator site network to every trial. By combining the best of our legacy experience with forward-thinking innovation, Fortrea brings predictability to clinical trial execution and helps transform aspirations into outcomes. Together, exceptional is possible. Learn more at Fortrea.com
Offices: Research Triangle Park, NC, US
