Clinical Research Associate II

PSI CRO AG

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

Posted 9/15/2026full-timeRemote • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in site management and monitoring within clinical trials, particularly in Oncology, ensuring compliance, data integrity, and effective communication with stakeholders. Proficient in managing study documentation and conducting training for site investigators.

Highest-signal resume keywords

Oncology ExperienceIndependent On-Site MonitoringSite Audit PreparationData Integrity ManagementMS Office Proficiency

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Site SelectionSource Data VerificationAdverse Event ReportingStudy Risk ManagementInvestigator Site File ReconciliationClinical Study Supply ManagementRegulatory Submission PreparationMonitoring Visit ExecutionStudy TMF ReviewSubject Recruitment Target Management

Soft Skills

Communication SkillsCollaboration SkillsProblem-Solving SkillsMultitasking AbilityDynamic Team Environment Adaptability

Industry Keywords

Life SciencesClinical TrialsPhases I-IIIInvestigational ProductsEthics Committee SubmissionAdverse EventsOn-Site MonitoringStudy AuditsSite ManagementIP-RED Packages

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
Manage the flow of documents and study supplies between project teams, sites, laboratories, reviewers, and warehouses
Conduct project-specific training of site investigators
Support preparation of Investigator newsletters
Assist Site Management Associates in maintaining study-specific and corporate tracking systems
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

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)
Must not require a work visa for employment or continued employment now or anytime in the future

Benefits

Comp & perks

Full-time employment
Remote work arrangement
Opportunity to further develop skills
Opportunity to widen therapeutic area experience
Opportunity to become an expert in clinical research