Overview
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.
Responsibilities
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.
Qualifications
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.