Site Start-up Specialist

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

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.

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.

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!

#LI-Remote #LI-Hybrid

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement. 

If, as a result of a disability, you require a reasonable accommodation to complete your job application, pre-employment testing, job interview or to otherwise participate in the hiring process, please contact: taaccommodationsrequest@fortrea.com. Please note that this e-mail address is only for job seekers requesting an accommodation. Please do not use this e-mail to check the status of your application.