Clinical Study Administrator

Parexel; Mississauga; Hybrid; CAD 42,000 - 62,000; Full time

Job summary

Parexel is seeking a capable clinical study administrator for a hybrid role in Mississauga, Ontario. The position supports start-up to closeout activities and ensures timely document submission and tracking within eTMF systems.

Key duties include coordinating with investigators, CRAs, and vendors, maintaining ISF/eTMF readiness, and assisting in regulatory document preparation. Fluent English and strong organizational skills are essential.

Qualifications

• High school/secondary qualifications adequate for the role.
• Prior administrative experience in life sciences preferred.
• Strong organizational and administrative capabilities.
• Proficient in English, both spoken and written.

Responsibilities

• Coordinate and administer clinical studies from start-up to closeout.
• Prepare and submit documents to EC/IRB and regulatory authorities.
• Maintain local eTMF and ISF in line with ICH-GCP.
• Liaise with Investigators, CRAs and vendors to support study delivery.
• Manage study materials, meetings and document distribution.

Skills

Organizational skills

Administrative support

Computer proficiency

English proficiency

Education

High school diploma

Further studies in administration (desirable)

Tools

CTMS (VCV)

SharePoint

eTMF systems

Job description

Parexel FSP has an exciting opportunity for a candidate looking to grow in clinical research. This is a hybrid role requiring 3 days a week on site in Mississauga ,Ontario.

Typical Accountabilities

• Assists in coordination and administration of clinical studies from the start-up to execution and closeout.
• Collects, assists in 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 local administrative main contact and works closely with the CRAs and/or the LSAD 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 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.
• Creates and/or imports clinical-regulatory documents into the Global Electronic Management System (e.g. ANGEL) ensuring compliance with the client’s Authoring Guide for Regulatory Documents.
• Contributes to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e., Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities.
• Sets-up, populates and accurately maintains information in client’s tracking and communication tools (e.g. CTMS such as VCV, SharePoint, etc) and supports others in the usage of these systems (with the exception of countries where there is a specific role dedicated to set up and update the systems).
• Prepares and/or supports contract preparation at a site level (with the exception of countries where there is a specific role dedicated to preparing site contracts).
• Prepares/supports/performs Health Care Organizations (HCO)/Health Care Professionals (HCP) payments in accordance with local regulations.
• 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, Investigators’ 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 layout and language control, copying and distribution of documents. Supports with local translation and spell checks in English to/from local language, as required.
• Responsible for printing and distribution of documents such as letters and meeting minutes, and for handling and archiving of study/country related e-mails.
• Interfaces with Data Management Centre and/or Data Management, Global Clinical Solutions representatives to facilitate the delivery of study related documents/material.
• Ensures compliance with client’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.

Essential

Education, Qualifications, Skills and Experience

• High school/Secondary school qualifications (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
• Previous administrative experience preferably in the medical/ life science field.
• Proven organizational and administrative skills.
• Computer proficiency.
• Good knowledge of spoken and written English.

Desirable

• Further studies in administration and/or in 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.