Remote Study Start-Up Specialist

NCBioImpact; Durham (NC); On-site; USD 50,000 - 70,000; Full time

Job summary

Fortrea seeks a Study Start Up Specialist with 2+ years of start-up experience residing in the U.S. The role interfaces with investigative sites as the primary contact during site activation and maintenance, ensuring regulatory submissions meet timelines and quality standards.

Responsibilities include preparing country applications, coordinating EC/IRB/Regulatory submissions, mentoring colleagues, and driving site activation strategies across regions to support project management goals.

Qualifications

• Bachelor's degree or certification in life sciences or related allied health field.
• 2+ years' work experience in clinical research/start-up.
• Knowledge of ICH guidelines and regulatory submissions.

Responsibilities

• Coordinate regulatory submissions with EC/IRB/Regulatory Authorities.
• Prepare study documentation such as country applications and cover letters for sponsor review.
• Mentor and train new hires in start-up activities where suitable.
• Ensure start-up activities align with timelines, budgets, and regulatory requirements.
• Act as local expert for start-up activities in assigned country/region.

Skills

Regulatory knowledge

Start-up experience

IRB/IEC regulations

Education

University/College degree (life science preferred)

Job description

Fortrea seeks a Study Start Up Specialist with 2+ years of start-up experience residing in the U.S. The role interfaces with investigative sites as the primary contact during site activation and maintenance, ensuring regulatory submissions meet timelines and quality standards.

Responsibilities include preparing country applications, coordinating EC/IRB/Regulatory submissions, mentoring colleagues, and driving site activation strategies across regions to support project management goals.