Sr. CRA 1, IQVIA

IQVIA; Carlsbad (CA); Presencial; USD 90.000 - 175.000; Jornada completa

Descripción de la vacante

IQVIA is seeking a Senior Clinical Research Associate 1 to manage site monitoring and coordination across assigned sites in the United States. The role emphasizes ensuring protocol compliance, regulatory adherence, and effective site performance through monitoring visits and training.

The candidate will track regulatory submissions, site recruitment, data queries, and documentation while collaborating with cross-functional teams to support study execution and startup activities.

Formación

• Bachelor's degree in a scientific discipline or health care preferred.
• At least 2 years of on-site monitoring experience.
• Good knowledge of clinical research regulatory requirements (GCP/ICH).
• Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.

Responsabilidades

• Perform site monitoring visits (selection, initiation, monitoring, close-out) per scope of work and GCP.
• Drive and track subject recruitment plans to enhance study predictability.
• Administer protocol training to sites and maintain regular communications.
• Evaluate site practices for protocol adherence and regulatory compliance; escalate issues as needed.
• Manage study progress: regulatory submissions, recruitment, CRF completion and data queries; may support startup.
• Maintain TMF/ISF documentation; ensure required filings.
• Collaborate with study team for project execution support.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate. Responsibilities Essential Functions
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Conocimientos

On-site monitoring experience

GCP & ICH guidelines

Regulatory knowledge

Regulatory requirements

Site management

Educación

Bachelor's Degree in scientific discipline or health care

Descripción del empleo

Durham, North Carolina, United States of America

Overland Park, KS, United States of America

Parsippany, New Jersey, United States of America

Carlsbad, CA, United States of America

Full time

R1570582

IQVIA is hiring Senior Clinical Research Associate 1 with experience in either oncology, cardiovascular, renal, metabolic, CNS, Obesity (GLP-1), diabetes, GI, MASH/NASH, dermatology, or respiratory:

Job Overview:

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Key Responsibilities:

• Perform site monitoring visits (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 plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate. Responsibilities Essential Functions
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications:

• Bachelor's Degree in scientific discipline or health care preferred.
• Requires at least 2 years of year 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.

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 https://jobs.iqvia.com

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. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $90,200.00 - $175,100.00. 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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