Clinical Study Administrator

Role Overview

Parexel's Functional Service Provider (FSP) team is seeking an enthusiastic Clinical Study Administrator (CSA) to support the administration and coordination of clinical trials. This position is based in Mississauga, Ontario, requiring onsite presence three days per week. The CSA plays a vital role in managing study activities throughout the entire clinical trial lifecycle, working closely with the Local Study Team (LST) to deliver study goals on time and within quality standards.

Key Responsibilities

• Coordinate and manage clinical study activities from initiation through execution to final closeout.
• Gather, assist in preparing, review, and monitor documents for regulatory submissions, facilitating timely submission to Ethics Committees/Institutional Review Boards (EC/IRB) and relevant Regulatory Authorities.
• Collaborate with Investigators, external vendors, and Clinical Research Associates (CRAs) to ensure effective document collection and study progression.
• Act as the main local administrative contact, coordinating closely with CRAs and Local Study Administrative Directors (LSADs).
• Maintain the local electronic Trial Master File (eTMF) and Investigator Site File (ISF), ensuring document tracking complies with ICH-GCP guidelines and local directives.
• Ensure essential documents are uploaded promptly to sustain eTMF readiness for inspections.
• Prepare study documentation for archiving and support CRA during ISF closeout processes.
• Contribute to creation and maintenance of study documents, ensuring adherence to templates and version control.
• Manage clinical-regulatory documentation within the Global Electronic Management System (e.g., ANGEL) according to client authoring standards.
• Support electronic regulatory submissions meeting Submission Ready Standards (SRS) for efficient regulatory authority delivery.
• Set up and update client tracking and communication systems (e.g., CTMS tools like VCV, SharePoint), offering assistance with their use.
• Assist in preparing site-level contracts unless another role is designated for this task.
• Administer or support payments to Health Care Organizations (HCO) and Health Care Professionals (HCP) conforming to local regulations.
• Oversee coordination and tracking of study-related materials and equipment.
• Manage administrative tasks during audits and regulatory inspections following company policies and SOPs.
• Organize logistics and contribute to preparing internal and external meetings such as study team, monitors’, and investigators’ meetings, liaising with internal/external participants and vendors aligned with international and local codes.
• Prepare and distribute presentation materials, newsletters, and website content related to the study.
• Manage document layout, proofreading, copying, distribution, translation support, and electronic mail archiving relevant to the study or country operations.
• Coordinate with Data Management teams and Global Clinical Solutions to facilitate delivery of study-related materials.
• Ensure adherence to client Code of Ethics, company policies on personnel, finance, technology, safety, health, and environment standards.
• Comply with applicable local, national, and regional laws and regulations.
• Perform additional country-specific tasks as needed based on local requirements.

Candidate Qualifications and Skills

• Minimum high school or equivalent secondary school qualifications that enable the successful performance of duties and effective communication with internal and external stakeholders.
• Prior administrative experience, preferably within medical or life science sectors.
• Strong organizational capabilities and administrative aptitude.
• Proficient computer skills.
• Fluent verbal and written English communication.

Preferred Attributes

• Advanced education in administration and/or life sciences is advantageous.
• Familiarity with clinical study processes, including working procedures and ICH-GCP guidelines.
• Willingness to develop enhanced computer skills to improve workflow efficiency.
• Effective verbal and written communication skills.
• Ability to work collaboratively in multicultural, international team environments.
• Readiness and capability to train colleagues on study administration procedures.
• Strong organizational discipline, excellent attention to detail, and capacity to manage multiple priorities in a dynamic environment.
• Team player with flexibility to adapt quickly to shifting priorities and new challenges.
• High ethical standards with integrity.