Clinical Study Administrator

Parexel FSP has an exciting opportunity for a candidate located in Ontario. This is a hybrid role with 3 days on site.

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

CSAs might have different internal titles based on the experience level (CSA, Senior CSA). The experience level depends on the years of experience, performance record, level of independence in the role, ability to take on additional tasks or tutor more junior colleagues. The Director, Country Head may assign this internal title after confirmation with Senior Director, Cluster Head / Executive Director, Regional Head.

Typical Accountabilities:

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

• 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 Organisations (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 web-sites.

• 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

Education, Qualifications, Skills and Experience

Essential:

• 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.

Key stakeholders and relationships

Internal (to client or team):

• Local Study Team including Local Study Associate Directors and CRAs

• Line Manager and local SMM LT

• Clinical Quality Associate Director

• Global Study Teams

• Local Regulatory Affairs

• Global Clinical Solutions functions

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

External (to client):

• Investigators and site personnel

• Study related vendors

• ECs/ IRB

• Regulatory Authorities

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