Study Start-Up Clinical Research Associate (SSU CRA)

This role is only open to Senior CRA's and is Paris based, 3 days ICON office based in Puteaux and 2 days remote.

As an SSU CRA, you will be responsible for coordinating and overseeing the study start-up phase of clinical trials. You will ensure all regulatory and ethical submissions are completed efficiently and to the highest standards. This role is primarily office-based in Paris with minimal travel requirements.

• Prepare, review, and coordinate regulatory submissions to ethics committees and health authorities.

• Oversee and drive site start-up activities including essential document collection and review, site regulatory packages, and contract/budget negotiations.

• Collaborate closely with clinical project managers, regulatory teams, and site staff to ensure timelines are met.

• Maintain study tracking tools to provide accurate updates on submission/approval progress.

• Support site identification and feasibility assessments where required.

• Ensure compliance with ICH-GCP, local regulatory requirements, and company SOPs.

• Participate in internal and sponsor meetings to report on SSU progress.

• Assist with audit readiness and respond to audit/inspection findings related to SSU activities.

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, or equivalent.

• You are an experienced Senior CRA in CRO or pharma.

• Knowledge of French regulatory environment and clinical trial requirements.

• Excellent organizational and communication skills.

• Fluent in French and English, both written and spoken.

• Ability to work independently in a dynamic, team-oriented environment.