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
Additional Information
