Global Study Associate

AstraZeneca • Durham, NC

7d

About The Position

The Global Study Associate (GSA) supports delivery of global clinical studies from set-up through maintenance, close-out, and archiving. The role supports the Global Study Director, Global Study Associate Director, and/or Global Study Manager with coordination, administration, systems, and other delegated aspects of clinical study execution. Work is performed in accordance with applicable clinical trial regulations, including ICH-GCP, AstraZeneca standard operating procedures, policies, best practices, and values. The GSA may work concurrently across multiple studies and delivery models.

The role includes supporting study documentation and regulatory submissions, maintaining the electronic Trial Master File, coordinating non-complex and non-critical-path vendors, and supporting study budgets, payments, supplies, transparency activities, meetings, audits, and inspections. The GSA may also contribute to non-drug process-improvement projects and perform other duties within the scope of the role.

AstraZeneca describes a collaborative environment that combines science, operations, and technology, encourages experimentation and the use of new tools, and emphasizes support, kindness, ambition, diversity, and inclusion. The position offers a competitive total rewards program, with compensation and benefits subject to the terms described in the posting.

Requirements

• Bachelor-level education in any discipline.
• At least 2 years of proven study administration, assistant, or other relevant study-level experience, including experience with the clinical study lifecycle.
• Proven organizational and analytical skills.
• Previous administrative training or experience.
• Computer proficiency for day-to-day tasks.
• Ability to develop working knowledge of the Clinical Study Process and related working procedures, and understanding of ICH-GCP guidelines.
• Excellent verbal and written communication skills in English.
• Ability to work independently and in a team environment.
• Ability to prepare presentation materials.
• Professionalism and mutual respect.
• Willingness and ability to train others on study administration procedures.
• Excellent organization and time-management skills, attention to detail, and ability to multitask in a high-volume environment with shifting priorities.

Nice To Haves

• A degree in a science or clinical research discipline is preferred.

Responsibilities

• Complete delegated study work in support of Global Study Directors, Global Study Associate Directors, and Global Study Managers, potentially across multiple studies and delivery models.
• Initiate and lead set-up of the electronic Trial Master File (eTMF), and maintain and close it in compliance with ICH-GCP and AstraZeneca SOPs.
• Provide oversight for non-complex, non-critical-path vendors and ensure compliance with study requirements and established processes.
• Collaborate with internal staff and external stakeholders to collect regulatory and other essential documents.
• Contribute to electronic regulatory applications and submissions by creating and managing clinical regulatory documents to technical standards and supporting publishing and delivery to regulatory authorities.
• Plan and collate administrative appendices for the Clinical Study Report (CSR).
• Initiate, maintain, or support the creation of study documents, ensuring compliance with templates and study-specific version requirements.
• Set up, populate, and maintain information in AstraZeneca tracking and communication tools, and support team members in using them.
• Support set-up, maintenance, and close-out of Clinical Trial Transparency activity in PharmaCM, coordinating with stakeholders to meet compliance and regulatory authority needs.
• Support study budget and payment tracking, reconciliation, and follow-up, including creating and maintaining purchase orders and running invoice and payment reports.
• Contribute to the application, coordination, supply, and tracking of study materials and equipment, and help collect study supplies at close-out if required.
• Coordinate and oversee administrative tasks and logistical support during study conduct, audits, and regulatory inspections in accordance with company policies and SOPs.
• Lead coordination of and contribute to preparation for internal and external meetings, including study team, committee, monitor, Investigator, and virtual meetings.
• Liaise with internal and external meeting participants and vendors.
• Prepare, contribute to, and distribute presentation materials for meetings, newsletters, and websites.
• Work on non-drug process-improvement projects or lead improvement projects as agreed with the manager.
• Perform other duties as assigned and within the scope of the role.

Benefits

• Competitive base salary, annual bonus, and long-term incentives.
• Generous paid time off program.
• Comprehensive benefits package.
• Qualified retirement program, including a 401(k) plan.
• Paid vacation and holidays.
• Paid leaves.
• Medical, prescription drug, dental, and vision coverage.
• Short-term incentive bonus opportunity.
• Eligibility to participate in an equity-based long-term incentive program for salaried roles.
• Retirement contribution for hourly roles.
• Commission payment eligibility for sales roles.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level