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Clinical Study Administrator

Location Wilmington, Delaware, United States Job ID R-117730 Date posted 25/08/2021

The Clinical Study Administrator (CSA) assists in the coordination and administration of the study activities from the start-up to execution and closeout, and within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost, and quality objectives.

Accountabilities:

  • Assists in coordination and administration of clinical studies from the start-up to execution and close-out

  • Collects assists in the preparation, reviews, and tracks documents for the application process. Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study.

  • Interfaces with Investigators, external service providers, and CRAs during the document collection process to support effective delivery of a study and its documents.

  • Serves as the local administrative main contact and works closely with the CRAs and/or the LSM for the duration of the study.

  • Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH- GCP and local requirements.

  • Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF “Inspection Readiness”.

  • Ensures that all study documents are ready for final archiving and completion of the local part of the eTMF and supports the CRA in the close-out activities for the ISF.

  • Contributes to the production and maintenance of study documents, ensuring template and version compliance.

  • Sets up, populates, and accurately maintains information in AstraZeneca tracking and communication tools (e.g. CTMS, SharePoint, etc) and supports others in the usage of these systems

  • Manages and contributes to coordination and tracking of study materials and equipment.

  • Coordinates administrative tasks during the study process, audits, and regulatory inspections, according to company policies and SOPs.

  • Leads the practical arrangements and contributes to the preparation of internal and external meetings e.g. study team meetings, Monitors’ meetings,. Liaises with internal and external

  • participants and/or vendors, in line with international and local codes.

  • Prepares contributes to, and distributes presentation material for meetings, newsletters, and websites.

  • Responsible for printing and distribution of documents such as letters and meeting minutes, and for handling and archiving of study/country-related e-mails.

  • Ensures compliance with AstraZeneca’s Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health, and Environment).

  • Ensures compliance with local, national, and regional legislation, as applicable.

Additional country-specific tasks might be added depending on local needs.

NB: The position is entry-level, and the standard role description includes all tasks, but some tasks may not be required. 

Education, Qualifications, Skills, and Experience

Essential:

  • Bachelor’s degree in sciences preferred plus 0-3 yrs’ experience that supports Skills and Capabilities of the position and ensures successful conduct of accountabilities/responsibilities and appropriate interactions with internal/external customers, or Associates degree in Sciences and 3+ pharmaceutical experience years of experience that supports Skills and Capabilities of the position and ensures successful conduct of accountabilities/responsibilities and appropriate interactions with internal/external customers required.

  • Previous clinical study experience with CDA/start-up process preferred.

  • Previous administrative experience preferably in the medical/ life science field.

  • Proven organizational and administrative skills.

  • Computer proficiency.

  • Good knowledge of spoken and written English.

  • Experience working with clinical sites is preferred.

Desirable:

  • Further studies in administration and/or in the life science field are desirable (*)

  • Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH-GCP guidelines.

  • Ability to develop advanced computer skills to increase efficiency in daily tasks.

  • Good verbal and written communication.

  • Good interpersonal skills and ability to work in an international team environment.

  • Willingness and ability to train others on study administration procedures.

  • Excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities.

  • Team-oriented and flexible; ability to respond quickly to shifting demands and opportunities.

  • Integrity and high ethical standards.

Key Stakeholders & Relationships

Internal: To AZ or the Team

  • Local Study Team including Local Study Managers and CRAs

  • Line Manager (ADSMM and local SMM LT)

  • Clinical Quality Manager

  • Global Study Teams

  • Local Regulatory Affairs

  • Enablement functions

* Medical Department personnel if CSA supports local studies (as per agreement by CH/CD and Medical Director)

External: To AZ

  • Investigators and site personnel

  • Study-related vendors

  • ECs/ IRB

  • Regulatory Authorities



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

50056677 C CDSM R&D BioPharmaceuticals

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