Solna, Stockholm County, Sweden · Remote OK
Join Our Team and Drive Clinical Research Success! At Fortrea, we are committed to accelerating clinical trials and ensuring regulatory compliance. As a Site Start-Up Specialist, you will play a pivotal role in coordinat…
Skills: Site Start-up, Regulatory Submissions, ICH/GCP Guidelines, Document Management, Clinical Research
Durham, California, United States · Hybrid
$100k–$112k/yr
Job Description Our FSP team is currently seeking a CRA 2 in California with 2 years of monitoring! May consider other West Coast states. 8-10 days on site per month being a mix of onsite and remote. WHAT YOU WILL DO You…
Skills: Clinical Monitoring, Site Management, Case Report Forms (CRF) Review, Serious Adverse Event (SAE) Reporting, Patient Protection
Madison, Wisconsin, United States · On-site
Fortrea is seeking an experienced EHS leader to play a critical role in advancing our global in the pivotal role of Senor Manager, Environment, Health, and Safety strategy. Partnering closely with site leaders and key st…
Skills: EHS Strategy, Regulatory Compliance, Hazard Assessments, Incident Investigations, Biosafety
Zurich, Zurich, Switzerland · Remote OK
Operating in approximately 100 countries, Fortrea we provide clinical development, patient access, and technology solutions that help deliver life-changing therapies to patients worldwide. As part of our continued growth…
Skills: Clinical Trial Agreements, Site Budgeting, Contract Negotiation, Stakeholder Management, Fair Market Value Guidance
Warsaw, Masovian Voivodeship, Poland · Remote OK
Fortrea is looking for an experienced Study Start-Up Lead to join our sponsor-dedicated team. If you enjoy leading study start-up activities, working with global teams, using data to drive smarter decisions, and helping …
Skills: Study Start-Up, Site Activation, Clinical Operations, Project Management, Trial Optimization
Dublin, Leinster, Ireland · Remote OK
Fortrea is looking for an experienced Study Start-Up Lead to join our sponsor-dedicated team. If you enjoy leading study start-up activities, working with global teams, using data to drive smarter decisions, and helping …
Skills: Study Start-Up, Site Activation, Clinical Operations, Project Management, Trial Optimization
Warsaw, Masovian Voivodeship, Poland · Remote OK
Fortrea is seeking an experienced Contract & Budget Lead to support a key client across the EMEA region. This is an exciting opportunity to play a critical role in clinical trial start-up by driving site contract and bud…
Skills: Site Budgeting, Contract Negotiation, Clinical Trial Agreements, Stakeholder Management, Fair Market Value Principles
Dublin, Leinster, Ireland · Remote OK
Fortrea is seeking an experienced Contract & Budget Lead to support a key client across the EMEA region. This is an exciting opportunity to play a critical role in clinical trial start-up by driving site contract and bud…
Skills: Site Budgeting, Contract Negotiation, Clinical Trial Agreements, Stakeholder Management, Clinical Trial Start-Up
Budapest, Central Hungary, Hungary · Hybrid
Join Our Team and Shape the Future of Clinical Research! At Fortrea, we are dedicated to streamlining clinical trials and ensuring compliance with global regulations. As a Site Budget & Contract Specialist, you will play…
Skills: Contract Negotiation, Clinical Research, ICH GCP Guidelines, Communication, Organizational Skills
Buenos Aires, Argentina · 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 Activation, ICH/GCP Guidelines, Regulatory Compliance, Site Management, Contract Negotiation
Budapest, Central Hungary, Hungary · Remote OK
Role objectives Manage escalations and review of assigned site budgets and contracts to ensure timely contract execution and study startup forecasts are achieved. Support the development of creative processes, methodolog…
Skills: Clinical Trial Agreements, Budget Negotiation, Contract Execution, Fair Market Value Guidance, Study Startup
Paris, Ile-de-France, France · Remote OK
At Fortrea, we believe in improving lives through the power of science, collaboration, and innovation. As a global CRO partner, we support mission-driven sponsors in bringing new therapies to the patients who need them. …
Skills: EU-CTR Submission Management, Site Activation Management, ICF Management, Quality Control, Process Development
Paris, Ile-de-France, France · Remote OK
Role objectives Manage escalations and review of assigned site budgets and contracts to ensure timely contract execution and study startup forecasts are achieved. Support the development of creative processes, methodolog…
Skills: Clinical Trial Agreements, Budget Negotiation, Site Contracting, Fair Market Value Guidance, Study Startup
Milan, Lombardy, Italy · Remote OK
$32k–$49k/yr
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 …
Skills: Site Monitoring, Site Management, Clinical Trial Management, Regulatory Compliance, Source Document Review
Zurich, Zurich, Switzerland · Remote OK
Join Our Team and Shape the Future of Clinical Research! At Fortrea, we are dedicated to streamlining clinical trials and ensuring compliance with global regulations. As a Site Budget & Contract Specialist (location: Swi…
Skills: Contract Negotiation, Clinical Research, ICH GCP Guidelines, Communication, Organizational Skills
Madrid, Community of Madrid, Spain · Remote OK
Join Our Team and Shape the Future of Clinical Research! At Fortrea, we are dedicated to streamlining clinical trials and ensuring compliance with global regulations. As a Site Budget & Contract Specialist, you will play…
Skills: Contract negotiation, Clinical research, ICH GCP guidelines, Legal documentation, Regulatory compliance
Warsaw, Masovian Voivodeship, Poland · On-site
Associate Talent Sourcing Specialist 6-Month Contract Location: Leeds, UK or Warsaw, Poland Help bring life-changing treatments to patients - without a medical degree! Every medical breakthrough starts with people. At Fo…
Skills: Talent Sourcing, Candidate Engagement, Market Mapping, Relationship Building, Research
Bucharest, Romania · On-site
At Fortrea, we believe in improving lives through the power of science, collaboration, and innovation. As a global CRO partner, we support mission-driven sponsors in bringing new therapies to the patients who need them. …
Skills: Study Start-Up, Site Activation, Clinical Operations, Project Management, ICF Creation
Toronto, Ontario, Canada · Remote OK
$80k–$145k/yr
Job Overview: Data Management leadership on studies and take responsibility for the development of the project documentation, system set-up, data entry and data validation procedures and processes assigned to more junior…
Skills: Clinical Data Management, Sponsor Management, Veeva EDC, Technical Mentoring, Budget Management
São Paulo, São Paulo, Brazil · On-site
Job Overview: The mission of the Project Management Academy (PM Academy) is to identify and develop potential clinical project management leaders of the future. Within a face-to-face, continuous learning environment, Pro…
Skills: Project Coordination, Clinical Project Management, Budget Tracking, Vendor Management, Risk Management
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The specialist coordinates site start-up activities and manages essential regulatory documents for clinical trials. They serve as the primary contact for investigative sites and ensure compliance with ICH/GCP guidelines and sponsor specifications.
Candidates need a university degree in life sciences or a related health profession and at least 2 years of experience in clinical research or site activation. Fluency in English, Swedish, and Finnish is preferred to support activities across Nordic regions.
Join Our Team and Drive Clinical Research Success!
At Fortrea, we are committed to accelerating clinical trials and ensuring regulatory compliance. As a Site Start-Up Specialist, you will play a pivotal role in coordinating site start-up activities, managing essential documents, and ensuring regulatory submissions are completed efficiently. Your expertise will help bring life-changing treatments to patients faster.
In this role, you will be part of our FSPx team and work directly with one of our renowned key sponsor to advance the development of innovative, life-changing medications.
This is full time, permanent and home based position.
Preferred Candidate Profile:
Fluency in both Swedish and Finnish, and able to support start-up activities across Finland, Sweden and Norway.
Key Responsibilities:
In this role, you will:
Serve as the primary contact for investigative sites during start-up and maintenance activities.
Collect, review, and organize essential documents required for regulatory submissions (EC/IRB/Third Body/Regulatory Authority).
Ensure compliance with ICH/GCP guidelines, regulatory requirements, and sponsor specifications.
Prepare and submit regulatory documents, including country-specific application forms and informed consent forms.
Track submission timelines and proactively address potential delays.
Collaborate with internal and external stakeholders, including vendors, clinical teams, and regulatory authorities.
Ensure all documentation is audit-ready and systems are consistently updated.
Assist in the negotiation of site contracts and budgets, if applicable.
Provide mentorship and training to new hires and less-experienced colleagues.
Required Qualifications:
To succeed in this role, you should have:
University/College degree (life sciences preferred) or certification in a related allied health profession.
Minimum 2 years of experience in clinical research, regulatory submissions, or site activation.
Strong knowledge of ICH/GCP guidelines, RA, IRB/IEC regulations, and start-up processes.
Ability to review and adapt patient informed consent forms to meet local and protocol-specific requirements.
Experience interacting with regulatory authorities and site start-up teams.
Excellent organizational, problem-solving, and communication skills.
Proficiency in Microsoft Office and document management systems.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Fluency in local language and English.
What We Offer:
Competitive salary and performance-based incentives.
Flexible work arrangements (remote/hybrid options).
Professional growth opportunities in a collaborative and innovative environment.
The opportunity to work on cutting-edge clinical research projects.
Ready to Make an Impact?
Join us in shaping the future of clinical research. Apply today!
Applications are reviewed on a rolling basis—don’t miss this opportunity!
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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
