Sr. CRA, Sponsor Aligned, Oncology

Carlsbad, CA - USA

Monthly Salary: $ 71900 - 189000

Posted on: 07-11-2025

Vacancies: 1 Vacancy

Job Summary

Job Overview
Conduct monitoring and site management tasks across various protocols sites and therapeutic areas.

Key Responsibilities

Site Monitoring Visits: Carry out site monitoring visits (selection initiation monitoring and close-out) in line with the contracted scope of work and regulatory requirements such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Subject Recruitment: Collaborate with sites to adapt drive and track subject recruitment plans to meet project needs and improve predictability.
Protocol Administration: Provide protocol and study-related training to assigned sites and maintain regular communication to manage ongoing project expectations and issues.
Quality Evaluation: Assess the quality and integrity of study site practices related to protocol adherence and regulatory compliance. Escalate quality issues as necessary.
Study Progress Management: Oversee the progress of assigned studies by tracking regulatory submissions and approvals recruitment and enrollment case report form (CRF) completion and submission and data query resolution. May assist with the start-up phase.
Document Management: Ensure site documents are available for filing in the Trial Master File (TMF) and verify that the Investigators Site File (ISF) is maintained according to GCP/ICH and local regulatory requirements.
Documentation: Create and maintain documentation regarding site management monitoring visit findings and action plans by submitting regular visit reports generating follow-up letters and other required study documentation.
Mentorship: Act as a mentor for clinical staff including conducting co-monitoring and training visits.
Collaboration: Work with study team members to support project execution as needed.
Recruitment Plan Development: If applicable support the development of project subject recruitment plans on a per-site basis.
Financial Management: If applicable manage site financials according to the clinical trial agreement and retrieve invoices as required by local regulations.

Qualifications

Education: Bachelors degree in a scientific discipline or healthcare preferred.
Experience: At least 1.5 years of on-site monitoring experience required. Equivalent combinations of education training and experience may be considered.
Regulatory Knowledge: In-depth knowledge of clinical research regulatory requirements including GCP and ICH guidelines.
Therapeutic and Protocol Knowledge: Strong understanding of therapeutic areas and protocols as provided in company training.
Technical Skills: Proficiency in Microsoft Word Excel and PowerPoint and the use of a laptop computer and iPhone/iPad (where applicable).
Communication Skills: Strong written and verbal communication skills with a good command of the English language.
Organizational Skills: Effective organizational and problem-solving abilities.
Time and Financial Management: Strong time and financial management skills.
Interpersonal Skills: Ability to establish and maintain effective working relationships with coworkers managers and clients.

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status as a protected veteran or any other status protected by applicable law. potential base pay range for this role when annualized is $71900.00 - $189000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge skills education and experience; location; and/or schedule (full or part-time). Dependent on the position offered incentive plans bonuses and/or other forms of compensation may be offered in addition to a range of health and welfare and/or other benefits.

Required Experience:

Senior IC

Job OverviewConduct monitoring and site management tasks across various protocols sites and therapeutic areas.Key ResponsibilitiesSite Monitoring Visits: Carry out site monitoring visits (selection initiation monitoring and close-out) in line with the contracted scope of work and regulatory requirem...

Job Overview
Conduct monitoring and site management tasks across various protocols sites and therapeutic areas.

Key Responsibilities

Site Monitoring Visits: Carry out site monitoring visits (selection initiation monitoring and close-out) in line with the contracted scope of work and regulatory requirements such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Subject Recruitment: Collaborate with sites to adapt drive and track subject recruitment plans to meet project needs and improve predictability.
Protocol Administration: Provide protocol and study-related training to assigned sites and maintain regular communication to manage ongoing project expectations and issues.
Quality Evaluation: Assess the quality and integrity of study site practices related to protocol adherence and regulatory compliance. Escalate quality issues as necessary.
Study Progress Management: Oversee the progress of assigned studies by tracking regulatory submissions and approvals recruitment and enrollment case report form (CRF) completion and submission and data query resolution. May assist with the start-up phase.
Document Management: Ensure site documents are available for filing in the Trial Master File (TMF) and verify that the Investigators Site File (ISF) is maintained according to GCP/ICH and local regulatory requirements.
Documentation: Create and maintain documentation regarding site management monitoring visit findings and action plans by submitting regular visit reports generating follow-up letters and other required study documentation.
Mentorship: Act as a mentor for clinical staff including conducting co-monitoring and training visits.
Collaboration: Work with study team members to support project execution as needed.
Recruitment Plan Development: If applicable support the development of project subject recruitment plans on a per-site basis.
Financial Management: If applicable manage site financials according to the clinical trial agreement and retrieve invoices as required by local regulations.

Qualifications

Education: Bachelors degree in a scientific discipline or healthcare preferred.
Experience: At least 1.5 years of on-site monitoring experience required. Equivalent combinations of education training and experience may be considered.
Regulatory Knowledge: In-depth knowledge of clinical research regulatory requirements including GCP and ICH guidelines.
Therapeutic and Protocol Knowledge: Strong understanding of therapeutic areas and protocols as provided in company training.
Technical Skills: Proficiency in Microsoft Word Excel and PowerPoint and the use of a laptop computer and iPhone/iPad (where applicable).
Communication Skills: Strong written and verbal communication skills with a good command of the English language.
Organizational Skills: Effective organizational and problem-solving abilities.
Time and Financial Management: Strong time and financial management skills.
Interpersonal Skills: Ability to establish and maintain effective working relationships with coworkers managers and clients.

Required Experience:

Senior IC

Key Skills

Hospital Experience
Acute Care
Basic Life Support
ICU Experience
Infusion Experience
Triage
TFS
Conflict Management
Nursing
Critical Care Experience
Epic
Medication Administration

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About Company

IQVIA

IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more

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