Description
Join Fortrea and drive clinical research success 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.
In this role, you will be part of the FSPx team and work directly with a renowned key sponsor to advance the development of innovative, life-changing medications.
Key Responsibilities:
- Serve as the primary contact for investigative sites during start-up and maintenance activities.
- Collect, review, and organize essential documents required for regulatory submissions.
- 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:
- 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.
- 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.