Clinical Research Associate II

PSI CRO AG; Canada; Remote; CAD 58,000 - 75,000; Full time

Job summary

An established industry player is seeking a Clinical Research Associate to join their dynamic team. This role offers the chance to work on diverse clinical studies while ensuring the highest quality standards in the industry. As the main point of contact between the project team and clinical sites, you will build strong relationships and oversee critical monitoring tasks. This is an excellent opportunity to enhance your skills and expand your experience in clinical research, particularly in oncology, while enjoying the flexibility of a remote position with significant travel opportunities. If you are passionate about making a difference in the healthcare field, this role is for you.

Qualifications

• 2+ years of independent on-site monitoring experience required.
• Full working proficiency in English and MS Office applications.

Responsibilities

• Act as the main line of communication between project team and site.
• Prepare, conduct, and report site selection and monitoring visits.

Skills

On-site monitoring experience

Communication skills

Problem-solving skills

Proficiency in MS Office

Ability to travel

Education

College/University degree in Life Sciences

Job description

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Company Description

PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Company Description

PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

As a Clinical Research Associate at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.

You will:

• Act as the main line of communication between the project team, sponsor, and the site
• Build and maintain a good relationship with the site staff involved in the study conduct
• Prepare, conduct, and report site selection, initiation, routine monitoring and close-out visits
• Ensure that subject recruitment targets are timely defined, communicated, recorded and met, and project timelines are followed at site level
• Ensure accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations
• Perform source data verification and follows up on data queries at site level; review and manage study risks on a site level
• Ensure proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on sites
• Review essential study documents and reconcile study Investigator Site File (ISF) / TMF at site level
• Ensures quality (data integrity and compliance) at site level
• Conduct site audit preparation visits and resolve site audit findings
• Participate in study site audits and client onsite visits, as required
• Ensure the flow of documents and study supplies between the project team, site and the Central/ Regional Laboratory/ Central Reviewer/ Warehouse
• Conduct project-specific training of site investigators
• Support preparation of Investigator newsletters
• Assist Site Management Associates in maintaining study-specific and corporate tracking systems at site level
• Support preparation of draft regulatory and ethics committee submission packages
• Support collection of IP-RED packages at site/country level
• Facilitate review and reconciliation of the study TMF on country and site levels
  
  
  

Qualifications

• College/University degree in Life Sciences or an equivalent combination of education, training & experience
• Located in Western Canada
• 2+ years of independent on-site monitoring experience
• Experience in all types of monitoring visits, in phases I-III
• Experience in Oncology highly preferred
• Full working proficiency in English
• Proficiency in MS Office applications
• Ability to plan, multitask and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills
• Ability to travel up to 75%
• Valid driver’s license (if applicable)
  
  
  

Additional Information

This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research

• Industries

  Pharmaceutical Manufacturing

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