The CRA will act as the primary contact with the investigative sites and be responsible for the oversight of all aspects of clinical research projects at the site level, assuring investigative site adherence to Good Clinical Practice (GCP) guidelines and compliance to Allphase and client study protocols.
- 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 in compliance 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
- Degree in life or medical sciences such as nursing, pharmacy or basic sciences. Advanced degree considered an asset.
- A minimum of three (3) years of experience in clinical research with primary site monitoring responsibilities.
- Excellent English and French communication skills (verbal and written).
- Demonstrated proficiency in Microsoft Office applications, specifically Word, Excel, PowerPoint and Outlook
- Valid driver’s license and passport are required
- Must be able to travel up to 60% of the time
- Dependable with excellent organizational, decision-making, and interpersonal skills
- Meticulous, autonomous and capable of working with minimal supervision
- Ability to handle competing priorities within a dynamic, deadline driven environment.
Only qualified candidates will be contacted for an interview.