This is a fully remote position, open to applicants in Romania, +2 more states.

• Facilitate the commencement of clinical trials and aid in the advancement of innovative treatments and therapies.

• Execute site start-up and activation tasks to a high standard.

• Prepare and submit regulatory documentation, such as clinical trial applications and ethics committee submissions.

• Coordinate with both internal and external stakeholders to secure approvals and authorizations for study initiation.

• Maintain precise and current records of regulatory submissions and approvals.

• Assist study teams in crafting protocols, informed consent forms, and investigator brochures.

• Engage in study start-up meetings and provide insights on regulatory requirements and timelines.

• Professional proficiency in English along with at least one of Norwegian, Danish, French, German, Spanish, or Portuguese.

• A bachelor's degree in life sciences or a related discipline.

• Relevant experience in site start-up and activation.

• Prior experience in clinical research or regulatory affairs is preferred.

• Strong attention to detail with excellent organizational skills.

• Outstanding communication and interpersonal abilities.

• Capability to collaborate effectively with cross-functional teams.

• Ability to work autonomously and manage multiple tasks concurrently in a fast-paced environment.

• Legal authorization to work in the country where the position is located.

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension schemes.

• Life insurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.

• Flexibility to work from home or in the office.

• Reasonable accommodations provided during the recruitment process.

Study Start Up Associate

People also viewed