Associate role supporting clinical trial initiation at a large CRO operating under a sponsor-dedicated model. Responsibilities include regulatory document preparation, stakeholder coordination, records management, and study team support to ensure compliant trial start-up.
Responsibilities
- Prepare and submit regulatory documents including clinical trial applications and ethics committee submissions
- Coordinate with internal and external stakeholders to obtain necessary study initiation approvals
- Maintain accurate records of all regulatory submissions and approvals
- Support study teams in developing protocols, informed consent forms, and investigator brochures
- Participate in start-up meetings and advise on regulatory requirements and timelines

Requirements
- Bachelor's degree in life sciences or related field
- Experience with submissions and amendments in regulatory context
- Clinical research or regulatory affairs background preferred
- Strong attention to detail and organizational abilities
- Excellent communication and cross-functional collaboration skills
- Ability to manage multiple tasks independently in fast-paced environment
- Willingness to travel approximately 5%

📌 Study Start Up Associate (España)
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📍 España