Study Start Up Associate II

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the preparation and submission of regulatory documents, such as clinical trial applications, ethics committee submissions, and communications with regulatory agencies.

• Facilitate coordination and communication with both internal and external stakeholders to secure approvals and authorizations for the initiation of studies.

• Ensure the management and maintenance of precise records related to regulatory submissions, approvals, and correspondence.

• Offer guidance and support to study teams concerning regulatory requirements and best practices for study start-up.

• Engage in process improvement initiatives aimed at optimizing study start-up processes and boosting efficiency.

• Gather, prepare, review, approve, process, and track essential regulatory and site-level documents needed for study site activation, adhering to relevant SOPs, regulations, guidelines, and ICH/GCP standards.

⛳️ Requirements

• A minimum of 1 year of clinical research experience in regulatory affairs, clinical research coordination, or study start-up activities.

• Experience at a clinical research site is preferred.

• Strong comprehension of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory standards.

• Exceptional organizational and project management abilities, with the capacity to prioritize and manage multiple tasks simultaneously.

• A proactive mindset and a strong desire to learn and acquire new skills.

• Outstanding communication and interpersonal skills, enabling effective collaboration with cross-functional teams.

• A bachelor's degree, ideally in life sciences, healthcare, or a related field.

• Legal authorization to work in the United States.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

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

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

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