Site Readiness and Regulatory Specialist 1
Fortrea
Full-time | Entry level
About the job
Fortrea, a global contract research organization (CRO), is a leader in clinical development and patient access, providing solutions to pharmaceutical, biotechnology, and medical device clients across more than 20 therapeutic areas. With over 19,000 employees operating in more than 90 countries, Fortrea is committed to transforming drug and device development.
As a Site Readiness and Regulatory Specialist 1, your responsibilities will include:
- Ensuring adherence to Standard Operating Procedures (SOPs).
- Managing and maintaining contract tracking, status systems, and both paper and electronic file systems.
- Assisting in processing and maintaining agreements in coordination with clinical study teams and contract status reporting.
- Supporting Contracts Specialists with populating, mailing, scanning, and tracking contracts.
- Participating in team discussions to improve departmental processes.
- Monitoring studies for compliance with internal processes or Sponsor requirements.
- Reviewing amendments such as clinical study documents, Protocols, and ICF amendments; negotiating contracts with sites and sponsors.
- Performing other department-related duties as assigned.
Skills
- Standard Operating Procedures (SOP)
- Timeline management
- Contract management
- Clinical study compliance
About Fortrea
Fortrea’s mission is to revolutionize clinical trials by overcoming challenges and speeding up the development of life-changing therapies. Join their team to collaborate in a global workspace designed for innovation and personal growth.
