Clinical Research Associate – Sponsor Dedicated

IQVIA

. Perform site monitoring visits, including selection, initiation, monitoring and close-out visits, in accordance with contracted scope of work and Good Clinical Practice.

Posted 10/9/2026full-timeUnited StatesJuniorMid-Level💰 $74,500 - $197,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Research Monitoring, including adherence to Good Clinical Practice (GCP) and regulatory requirements. Proficient in managing site communications, recruitment plans, and documentation for clinical trials.

Highest-signal resume keywords

Clinical Research Associate (CRA) ExperienceGood Clinical Practice (GCP) KnowledgeRegulatory Compliance SkillsProficiency in EDC and CTMSEffective Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site MonitoringProtocol Compliance EvaluationData Query GenerationStudy Training AdministrationProject Execution Support

Soft Skills

Organizational SkillsProblem-Solving SkillsTime Management SkillsRelationship Management

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft PowerPointETMFIVRS/IWRS

Industry Keywords

Clinical TrialsGood Clinical Practice (GCP)International Conference on Harmonization (ICH)Trial Master File (TMF)Investigator's Site File (ISF)

About the role

Key responsibilities & impact

Perform site monitoring visits, including selection, initiation, monitoring and close-out visits, in accordance with contracted scope of work and Good Clinical Practice.
Work with sites to adapt, drive and track subject recruitment plans.
Administer protocol and related study training to assigned sites.
Establish regular communication with sites to manage project expectations and issues.
Evaluate study site practices for protocol compliance and adherence to regulations.
Escalate 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 (TMF) filing.
Verify Investigator's Site File (ISF) maintenance according to GCP and local regulatory requirements.
Create and maintain site management and monitoring documentation, including visit reports and follow-up letters.
Collaborate with study team members to support project execution.
Support development of project subject recruitment plans on a per-site basis when applicable.
Support site financial management and invoice retrieval according to clinical trial agreements and local requirements when applicable.

Requirements

What you’ll need

Bachelor's Degree Degree in scientific discipline or health care preferred.
Requires at least 2 years of independent on-site monitoring experience as a Clinical Research Associate (CRA) in a CRO, sponsor, or similar setting.
Equivalent combination of education, training and experience may be accepted in lieu of degree.
Good knowledge of applicable clinical research regulatory requirements.
Skill in applying Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Good therapeutic and protocol knowledge as provided in company training.
Proficiency in Microsoft Word, Excel and PowerPoint.
Ability to use a laptop computer, iPhone and iPad (where applicable).
Experience utilizing EDC, CTMS, eTMF, IVRS/IWRS, and other clinical trial systems.
Written and verbal communication skills including good command of English language.
Organizational and problem-solving skills.
Effective time and financial management skills.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Must reside in the same country where the job is located.

Benefits

Comp & perks

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