Clinical Study Administrator

AstraZeneca•Wilmington, DE

About The Position

The Clinical Study Administrator will be responsible for the coordination and administration of clinical studies from start-up through execution and close-out. This role acts as the main local administrative contact and works closely with CRAs and/or LSAD for the duration of assigned studies. The administrator will coordinate administrative tasks during the study process, audits, and regulatory inspections in line with company policies and SOPs. They will also support the collection, preparation, review, and tracking of documents for the application process and timely submissions to Ethics Committees/Institutional Review Boards (EC/IRB) and Regulatory Authorities. Operational responsibility for the correct set-up and ongoing maintenance of the local electronic Trial Master File (eTMF) and Investigator Study File (ISF) is crucial, ensuring document tracking in accordance with ICH-GCP and local requirements to maintain inspection readiness. The role involves managing clinical-regulatory documents in the Global Regulatory management system and for electronic applications and submissions, complying with Submission Ready Standards (SRS). Additionally, the administrator will serve as the primary point of contact for legal negotiations related to confidentiality agreements and amendments, process study-level and site-level amendments, and prepare/support site-level contract preparation. They will also be responsible for processing payments to Health Care Organisations (HCO) and Health Care Professionals (HCP) in accordance with local regulations. The role requires setting up, populating, and accurately maintaining information in AstraZeneca tracking and communication tools (e.g., Clinical Trial Management System [CTMS]) and managing/coordinating study materials and equipment. Stakeholder engagement includes interfacing with investigators, external service providers, and CRAs, and leading practical arrangements for meetings. The administrator must ensure compliance with AstraZeneca’s Code of Ethics, policies, and procedures, and adhere to all relevant local, national, and regional legislation.

Requirements

Bachelors degree aligned to the knowledge and skills required for the role.
0 + experience required
Relevant knowledge of the drug development process, international guidelines (ICH‑GCP) and applicable country regulations.
Personal effectiveness and strong self‑accountability.
Learning agility.
Financial, technology and process competency.
Active listening and fluency in written and spoken business‑level English.
High integrity and ethical standards.
Ability to work effectively as part of a team in both in‑person and virtual settings; demonstrates cultural awareness.
Ability to identify and champion more efficient delivery of quality clinical trials with optimised cost and time.
Ability to travel nationally and internationally, as required.
Valid driving licence, if required by country of employment.
Strong communication and teamwork skills, including collaboration, business partnering and impactful site conversations.
Effective, risk‑based thinking, including planning and alignment, problem solving, critical thinking and decision making.
Clinical study operations (GCP) and quality management, including Good Documentation Practice (GDP).

Responsibilities

Assist the Local Study Team with the coordination and administration of clinical studies from start‑up through execution and close‑out.
Act as the main local administrative contact and work closely with CRAs and/or LSAD for the duration of assigned studies.
Coordinate administrative tasks during the study process, audits and regulatory inspections in line with company policies and SOPs.
Support the collection, preparation, review and tracking of documents required for the application process.
Support the Study Start‑up team with timely submissions to Ethics Committees/Institutional Review Boards (EC/IRB) and, where applicable, Regulatory Authorities.
Take operational responsibility for correct set‑up and ongoing maintenance of the local electronic Trial Master File (eTMF) and Investigator Study File (ISF), ensuring document tracking in accordance with ICH‑GCP and local requirements to maintain inspection readiness.
Ensure all study documents are prepared for final archiving and support CRAs with ISF close‑out activities.
Contribute to the production and maintenance of study documents, ensuring compliance with required templates and versions.
Manage clinical‑regulatory documents in the Global Regulatory management system, as required.
Manage clinical‑regulatory documents for electronic applications and submissions, complying with Submission Ready Standards (SRS) to support efficient publishing and delivery to regulatory authorities, where applicable.
Serve as primary point of contact for legal negotiations related to confidentiality agreements and amendments.
Process study‑level and site‑level amendments.
Prepare and/or support site‑level contract preparation, except where a specific local role is assigned.
Prepare, support and perform payments to Health Care Organisations (HCO) and Health Care Professionals (HCP) in accordance with local regulations.
Set up, populate and accurately maintain information in AstraZeneca tracking and communication tools (e.g. Clinical Trial Management System [CTMS]) and support others in the use of these systems, except in countries with a designated system administrator.
Manage and contribute to the coordination and tracking of study materials and equipment.
Interface with Data Management Centres and/or Global Clinical Solution representatives to support delivery of study‑related documents and materials.
Interface with investigators, external service providers and Clinical Research Associates (CRAs) to facilitate effective document collection and study delivery.
Lead practical arrangements for internal and external meetings (e.g. study team meetings, monitors’ meetings, investigators’ meetings), liaising with internal and external participants and vendors in line with applicable international and local codes.
Prepare, contribute to and distribute material for meetings, newsletters and web content, in alignment with LST and global stakeholders.
Perform document layout and language checks, as well as copying and distribution.
Provide support for local translation and English language checks, as required.
Handle printing and distribution of documents (e.g. letters, meeting minutes) and manage and archive study‑ and country‑related emails.
Ensure compliance with AstraZeneca’s Code of Ethics, policies and procedures, including those related to people, finance, technology, security and Safety, Health and Environment (SHE).
Adhere to all relevant local, national and regional legislation.
Carry out additional country‑specific tasks in accordance with local organisational needs, when assigned.