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. 

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.

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 $93,249.60 - $139,874.40 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. 

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.