Date : August, 01, 2024
Expected Travel : Up to 80%
Division: Pharma – Clinical Research
Do YOU want to join one of Canada’s fastest growing Contract Research Organizations (CRO) that is dedicated to providing quality and service excellence to our pharmaceutical and biotechnology clients and their customers?
Calian CRO is seeking an experienced Bilingual Clinical Research Associate (CRA) in Montreal, QC, and surrounding areas for an exciting opportunity to work within our dynamic team. The CRA will act as the primary contact with the investigative sites and will be responsible for the oversight of all aspects of clinical trials at the site level, assuring investigative site adherence to Good Clinical Practice (GCP) guidelines and compliance to Calian CRO and client SOPs and study protocols.
If you are self-motivated and enjoy managing your own schedule, this is a terrific opportunity for you!
Your Responsibilities:
- Perform site selection, site initiation, interim monitoring and site closure visits
- Ensure reported data are accurate, complete, and verifiable from source documents
- Ensure the conduct of the study is compliant with the currently approved protocol/amendment(s), with current GCP guidelines and with applicable regulatory requirements
- Ensure the rights and well-being of human subjects are protected
- Verify that SAE reporting is accurate and in accordance with the protocol, GCP guidelines and with applicable regulatory requirements
- Conduct Investigational Product Accountability
- Coordinate investigator and study meetings, including preparation and presentation of information and training investigative site staff on protocol, study conduct, GCP Guidelines & regulatory requirements
- Document clinical trial progress to ensure completeness of documentation and data collection, management of supplies and resources in adherence with the project timelines, budgets and quality standards
- Complete investigative site file reconciliation: request new or updated site-related essential and non-essential documents and analyze for accuracy, content, consistency and compliance
- Monitor clinical trial progress for compliance with regulatory and budgetary requirements
- Complete visit or trip reports at the conclusion of each monitoring visit according to company and sponsor standard operating procedures (SOPs)
- Interact with internal groups including data management, quality assurance and business development during clinical study lifecycle
- Assist the clinical study team with the development of clinical protocols, case report forms and clinical study reports
- Fulfill other Duties as Required
What you need to Qualify:
- Degree in life or medical sciences such as nursing, pharmacy or basic sciences. Advanced degree considered an asset.
- A minimum of 3 years of site monitoring experience for a pharma company or a CRO, conducting Site initiation visits, site selection visits and monitoring visits.
- Excellent communication skills in French and English is a MUST.
- Demonstrated proficiency in Microsoft Office applications, specifically Word, Excel, PowerPoint and Outlook.
- Valid driver’s license and passport are required.
- Dependable with excellent organizational, decision-making, and interpersonal skills.
- Meticulous, autonomous and capable of working in a home-based office with minimal supervision.
- Ability to handle competing priorities within a dynamic, deadline driven environment.
We look forward to reviewing your application!