Senior CRA 1

IQVIA

. Perform site monitoring visits, including selection, initiation, monitoring, and close-out visits.

Posted 10/30/2026full-timeUnited StatesSenior💰 $90,200 - $190,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in site monitoring, regulatory compliance, and clinical trial management, with a strong focus on Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Proficient in developing and executing subject recruitment plans while ensuring adherence to protocol and regulatory standards.

Highest-signal resume keywords

Site Monitoring ExperienceGood Clinical Practice (GCP)International Conference on Harmonization (ICH)Regulatory ComplianceClinical Trial Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site MonitoringRegulatory SubmissionsProtocol AdministrationData Query ResolutionTrial Master File ManagementSite Management DocumentationSubject Recruitment PlanningQuality Issue EscalationCRF CompletionFinancial Management

Soft Skills

CommunicationCollaborationProblem-SolvingProject Management

Industry Keywords

Clinical ResearchOncologyCardiovascularRenalMetabolicCNSDiabetesGIDermatologyRespiratory

About the role

Key responsibilities & impact

Perform site monitoring visits, including selection, initiation, monitoring, and close-out visits.
Work with sites to adapt, drive, and track subject recruitment plans.
Administer protocol and study training to assigned sites and establish regular communication to manage project expectations and issues.
Evaluate study site practices for protocol conduct and regulatory adherence, escalating quality issues as appropriate.
Track regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data query generation and resolution.
Support the study start-up phase when applicable.
Ensure site documents are available for Trial Master File filing and verify Investigator's Site File maintenance.
Create and maintain site management documentation, monitoring visit findings, action plans, visit reports, and follow-up letters.
Collaborate with study team members to support project execution.
Support development of site-level subject recruitment plans when applicable.
Manage site finances according to clinical trial agreements and retrieve invoices according to local requirements when applicable.

Requirements

What you’ll need

Bachelor's Degree in scientific discipline or health care preferred.
Requires at least 2 years of on-site monitoring experience.
Equivalent combination of education, training and experience may be accepted in lieu of degree.
Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Good therapeutic and protocol knowledge as provided in company training.
Experience in either oncology, cardiovascular, renal, metabolic, CNS, Obesity (GLP-1), diabetes, GI, MASH/NASH, dermatology, or respiratory.

Benefits

Comp & perks

Health and welfare benefits
Incentive plans, bonuses, and/or other forms of compensation may be offered