Contract Clinical Research Associate

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 Canada (West Coast)

• 5+ years of independent on-site monitoring experience

• Experience in all types of monitoring visits, in phases I-III

• Experience independently monitoring Oncology clinical trials required

• Experience independently monitoring Gastroenterology (IBD) clinical trials required

• 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