Clinical Research Associate

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?

At **Allphase Clinical Research**, we continually strive to expand our knowledge base and experience by hiring talented people to further our remarkable growth. Our aim is to find the right people for the right roles to deliver services in line with industry best practices.
- Do you have a passion to make a positive difference for others?
- Are you a team player striving for continuous improvement?
- Are you driven by high quality clinical data and ensuring excellent service?
- Do you enjoy being faced with a challenge and troubleshooting innovative solutions?
- Are you flexible and able to adapt to an evolving and dynamic work environment?
- Do you want to make an impact and be recognized for your contributions?
- Do you want advancement opportunities (and/or an opportunity for exposure to other clinical trial roles)?

If you have answered YES, we encourage you to apply

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, local regulations and compliance to Allphase and client SOPs and study protocols. If you are well organized, self-motivated, and detail-oriented, this is a terrific opportunity for you

**Your Responsibilities**:

- Perform site selection, site initiation, interim monitoring, remote 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
- 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, pharmacovigilance, quality assurance and business development during clinical study lifecycle
- 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.
- Excellent communication in English and French (verbal and written).
- 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 secure home-based office with mínimal supervision.
- Ability to handle competing priorities within a dynamic, deadline driven environment.

**About Allphase**

Allphase Clinical Research Inc., a Calian company (TSX: CGY), is a Canadian-owned Contract Research Organization (CRO) celebrating 20 years of providing high quality clinical trial management for companies with early-stage (Phase II) to post-market approval products (Phase IV) in a variety of therapeutic areas.

The Allphase family is driven by the goal of exceeding our customers’ expectations through continuous improvement, innovation, collaboration, leadership, and quality deliverables. Our culture is one of passion, respect, innovation, and teamwork.