Remote Study Start-Up Specialist (Clinical Trials)

Fortrea; United States; Remote; USD 50,000 - 70,000; Full time

Job summary

Fortrea in the United States is seeking a Study Start-Up Specialist with 2+ years of start-up experience to serve as the primary site contact during activation and maintenance, ensuring regulatory submissions meet timelines and sponsor requirements. You will collect essential documents, coordinate with EC/IRB/Regulatory Authorities, mentor new hires, and ensure adherence to ICH/GCP and SOPs.

Travel domestically and internationally is expected.

Qualifications

• 2+ years of clinical research experience with a focus on start-up activities.
• Strong knowledge of ICH guidelines and RA, IRB/IEC regulations.
• Bachelor's degree in life sciences or related allied health field required or equivalent experience.

Responsibilities

• Serve as primary contact for investigative sites during start-up and maintenance.
• Coordinate and collect documents for EC/IRB/Regulatory submissions.
• Prepare study documentation such as country application forms and cover letters.
• Liaise with internal and external vendors for regulatory submissions.
• Ensure compliance with ICH/GCP, SOPs, and quality standards.

Skills

Study start-up experience

Regulatory knowledge

Mentoring

Education

Bachelor's degree in Life Sciences

Clinical Research Certification

Job description

Fortrea in the United States is seeking a Study Start-Up Specialist with 2+ years of start-up experience to serve as the primary site contact during activation and maintenance, ensuring regulatory submissions meet timelines and sponsor requirements. You will collect essential documents, coordinate with EC/IRB/Regulatory Authorities, mentor new hires, and ensure adherence to ICH/GCP and SOPs.

Travel domestically and internationally is expected.