Clinical Research Associate II

PSI CRO AG

. Act as the main line of communication between the project team, sponsor, and the site .

Posted 9/23/2026full-timeRemote • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in site monitoring and management, ensuring compliance and data integrity throughout clinical trials. Proficient in building relationships with site staff and effectively communicating project timelines and recruitment targets.

Highest-signal resume keywords

On-Site Monitoring ExperienceClinical Trial ManagementData Integrity AssuranceOncology ExperienceMS Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site SelectionSource Data VerificationAdverse Event ReportingStudy Risk ManagementInvestigator Site File ReconciliationClinical Study Supply ManagementStudy Audit PreparationRegulatory Submission PreparationProject-Specific TrainingMonitoring Visit Experience

Soft Skills

Communication SkillsCollaboration SkillsProblem-Solving SkillsMultitasking AbilityTeamwork

Industry Keywords

Life SciencesClinical TrialsPhases I-IIIOncologyGastrointestinal ExperienceRadio-Pharmaceutical ExperienceInvestigational ProductsTrial Master FileEthics Committee SubmissionAdverse Events

About the role

Key responsibilities & impact

Act as the main line of communication between the project team, sponsor, and the site
Build and maintain relationships with site staff involved in study conduct
Prepare, conduct, and report site selection, initiation, routine monitoring, and close-out visits
Define, communicate, record, and meet subject recruitment targets and follow project timelines at site level
Ensure accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations
Perform source data verification and follow up on data queries at site level
Review and manage study risks at site level
Ensure proper handling, accountability, reconciliation, and return of Investigational Products and clinical study supplies
Review essential study documents and reconcile Investigator Site File / TMF at site level
Ensure 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
Coordinate documents and study supplies between project team, site, laboratories, reviewers, and warehouse
Conduct project-specific training of site investigators
Support preparation of Investigator newsletters
Assist Site Management Associates with study-specific and corporate tracking systems
Support preparation of 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

Requirements

What you’ll need

College/University degree in Life Sciences or an equivalent combination of education, training & experience
Located in the Central or West Coast regions is preferred
2+ years of independent on-site monitoring experience
Experience in all types of monitoring visits, in phases I-III
Experience in Oncology mandatory
GI experience 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)
PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future

Benefits

Comp & perks

Employees can work remotely
Opportunity to further develop skills, widen therapeutic area experience, and become an expert in clinical research