Clinical Study Administrator

TheSSU CSAassistsin 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 supporttimelysite activation whilemaintainingquality and costobjectives.

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 onadditionalresponsibilities as assigned by the SSU Manager.

Education, Qualifications,Skillsand Experience (Minimum)

• Education: High school completion and post-secondary studies preferred; field of study flexible.

• 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.

• Computerproficiency:Proficiencywith common office productivity tools (e.g.,Microsoft Office, Google Workspace).

• Language:Proficiencyin spoken and written English.

Typical Accountabilities

• Assist the SSU Manager with obtaining andmaintainingessential 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, andmaintaininformation in tracking and communication tools (trainingprovided;e.g., Veeva Clinical, Box), and support others in the usage of these systems.

• Process vendorsaccessto prepare clinical sites for activation.

Desirable Qualifications,Skillsand 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 onstudyadministration procedures after onboarding.

• Integrity and high ethical standards.

Why AstraZeneca? At AstraZeneca, we are committed to being an inclusive employer and encourage applicants from all backgrounds to apply. We are ready to welcome someone who is entrepreneurial, thinks big, and is eager to work together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, join us in pushing the boundaries of science to deliver life-changing medicines.

Where You Can Learn More

·       Follow AstraZeneca on LinkedIn

·       Follow AstraZeneca on Facebook

·       Follow AstraZeneca on Instagram

Benefits

We offer a competitive Total Reward program, including:

·       Competitive base salary, annual bonus, and long-term incentives

·       Generous paid time off program

·       Comprehensive benefits package

Diversity and Inclusion at AstraZeneca
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive team that represents a diverse group of backgrounds and perspectives, knowing that inclusion drives better outcomes.We welcome all qualified candidates and align with applicable laws regarding inclusivity and employment eligibility. Individuals with disabilities can request reasonable accommodations during the application or interview process, as well as for essential job functions.

The annual base pay (or hourly rate of compensation) for this position ranges from $82,249.60 - $123,374.40 USD Annual, either as annual base pay or as the hourly rate (annual base pay divided by 2080 hours)]. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.