Clinical Study Administrator

The SSU CSA assists in the coordination and administration of study activities from Site Selection through Site Activation. The SSU CSA works under the guidance of the SSU Manager to support timely site activation while maintaining quality and cost objectives. 

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. 

• With tenure and experience, take on additional responsibilities as assigned by the SSU Manager. 

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). Internship/co-op experience may count toward this requirement.

• 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 

• Assist 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. 

Desirable Qualifications, Skills and 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.