Clinical Study Administrator

Key Responsibilities

• Ensure tracking spreadsheets and logs are completed accurately and processed according to study team guidelines.
• Review and process Sub-Investigator documents; attend weekly Study Team meetings to report on tracking status and document progression.
• Perform responsibilities according to AZ Procedural Documents, international guidelines such as ICH and GCP, and relevant local regulations.

Essential Skills/Experience

• Education: High school diploma or GED required. Bachelor’s degree in Life Sciences, Healthcare, Pharmacy, Nursing, or a related field preferred; an Associate’s degree or an equivalent combination of education and relevant experience will be considered.
• Experience: 1–3 years of relevant experience in clinical research, study start-up, or regulated administrative support (e.g., pharmaceutical, CRO, or healthcare setting).
• Communication: Strong verbal and written communication skills.
• Organization: Strong organizational skills; attention to detail; ability to multi-task in a high-volume environment with shifting priorities.
• Teamwork and adaptability: Team oriented and flexible; able to respond quickly to changing demands.
• Computer proficiency: Proficiency with common office productivity tools (e.g., Microsoft Office, Google Workspace).
• Language: Proficiency in spoken and written English.

Desirable Skills/Experience

• Willingness and ability to develop advanced computer skills to increase efficiency in day-to-day tasks.
• Good interpersonal skills and ability to work in an international team environment.
• Willingness and ability to train others on study administration procedures after onboarding.
• Integrity and high ethical standards.

Typical Accountabilities

• Aid the SSU Manager with obtaining and maintaining essential documents in compliance with ICH-GCP and AZ Procedural Documents.
• Review and process start-up documents, including Sub-Investigator documents, per ICH-GCP and AZ Procedural Documents.
• Support delivery of regulatory documents at sites; proactively flag potential delays and risks to activation plans to the SSU Manager.
• Attend study team meetings prepared to provide status updates on tracking tools and document workflows.
• Set up, populate, and maintain information in tracking and communication tools (training provided; e.g., Veeva Clinical, Box), and support others in the usage of these systems.
• Process vendors access to prepare clinical sites for activation.

Pay

$93,249.60 - $139,874.40 USD annually

Schedule

Full-time