Clinical Research Associate II

Responsibilities

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

Preferred

Located in the Central or West Coast regions is preferred

Glassdoor

4.1

PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.

Zug, Zug, CHE

https://www.psi-cro.com/

Late Stage

Recent News

PR Newswire

PSI Reduces Clinical Trial Site Identification From Weeks to Minutes Using AI Agent Powered by Arango Contextual Data Platform

2026-03-19

BioSpace

Mirum Pharmaceuticals Provides AZURE Clinical Program Update for brelovitug in Chronic Hepatitis Delta Virus

2026-03-05

PharmiWeb

PSI CRO Strengthens Canadian Presence with New Toronto Office and Leadership Role

2026-01-08

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Qualifications

College/University degree in Life Sciences or an equivalent combination of education, training & experience

Must have 2+ years of independent on-site monitoring experience

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

Experience in Oncology mandatory & GI preferred and/or radio-pharm experience 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)

Located in the Central or West Coast regions is preferred

Required skills

Clinical research monitoring, On-site monitoring, Phase I-III clinical trials, Oncology, Gastrointestinal (GI) clinical research, Radiopharmaceutical clinical research, MS Office

Preferred skills

Located in the Central or West Coast regions is preferred, Glassdoor, 4.1, Zug, Zug, CHE, https://www.psi-cro.com/, Late Stage, Recent News, PR Newswire, 2026-03-19, BioSpace, 2026-03-05, PharmiWeb, 2026-01-08, Company data provided by, AI Tools, Customize Your Resume, Maximize your interview chances, Build Cover Letter, Make your application stand out, Analyze How Well You Fit, Understand your strength & weakness

Experience

2+ years