Clinical Research Associate, Sponsor Dedicated

Regulatory Toolkit; Carlsbad (CA); On-site; USD 72,000 - 189,000; Full time

Job summary

IQVIA is seeking a Clinical Research Associate to monitor study sites and ensure compliant data reporting per protocol and regulatory guidelines. The role requires on-site visits, coordination with investigative sites, and documentation in the TMF/ISF.

Strong English communication and regulatory knowledge are essential. Responsibilities include site initiation, monitoring, close-out visits, training, and tracking regulatory submissions, recruitment, and data queries.

Qualifications

• Requires minimum 1 year of independent on-site monitoring experience as a CRA.
• Bachelor's Degree in scientific discipline or health care preferred.
• Knowledge of GCP/ICH guidelines and related regulations.
• Proficient in MS Word, Excel, PowerPoint; familiarity with iPhone/iPad is a plus.
• Strong English written and verbal communication, organizational and problem-solving skills.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope and GCP/ICH.
• Collaborate with sites to drive subject recruitment plans.
• Administer protocol training and maintain regular communication with sites.
• Track regulatory submissions, recruitment, CRF completion, and data queries.
• Ensure TMF/ISF documentation is accurate and up to date.
• Coordinate with study team for project execution.

Skills

On-site monitoring

English communication

Regulatory knowledge (GCP/ICH)

Education

Bachelor's Degree in scientific discipline or health care preferred

Tools

Microsoft Word

Excel

PowerPoint

iPhone

iPad

Job description

To be eligible for this position, you must reside in the same country where the job is located.

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.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• 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.
• 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

• Requires a minimum of 1 year of independent on-site monitoring experience as a Clinical Research Associate (CRA).
• Bachelor's Degree in scientific discipline or health care preferred.
• 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 (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• 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.

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 $71,900.00 - $189,000.00. 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.