Clinical Research Associate II - MedTech

IQVIA Inc; Paradise (NV); Presencial; USD 90.000 - 150.000; Jornada completa

Descripción de la vacante

IQVIA is a leading global provider of clinical research services. We are hiring a monitor to perform site visits, manage site communications, and ensure data quality and regulatory compliance for studies conducted at US sites.

You will work to drive recruitment plans and maintain rigorous documentation. The role requires on-site monitoring experience, knowledge of GCP/ICH, and strong organizational, communication, and problem-solving skills.

Formación

• Bachelor's Degree in scientific discipline or health care preferred. Req
• Requires at least 1 year of on-site monitoring experience. Req
• Equivalent combination of education, training and experience may be accepted in lieu of degree. Req
• 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 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.

Responsabilidades

• Perform monitoring visits (selection, initiation, monitoring and close-out) in line with scope and GCP/ICH guidelines.
• Collaborate with sites to drive recruitment plans and improve predictability.
• Administer protocol training and maintain regular site communications to manage expectations.
• Evaluate site practices for protocol conduct and regulatory adherence; escalate issues as needed.
• Track regulatory submissions, recruitment, CRF completion, data queries; support start-up as needed.
• Maintain TMF and ISF documentation in compliance with regulations.
• Create and maintain site management documentation, visit reports, and follow-up letters.
• Coordinate with study team members for project execution support.
• Support development of site recruitment plans and, if applicable, site financial management.

Conocimientos

Communication skills

Organizational skills

Problem-solving

Time management

Financial management

Relationship building

Written and verbal English

Educación

Bachelor's Degree in scientific discipline or health care

Herramientas

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

iPhone and iPad

Descripción del empleo

MCRA is part of IQVIA MedTech. As a trusted CRO and advisory partner, IQVIA MedTech and MCRA deliver integrated lifecycle solutions for the medical device and diagnostics industry. Together, we support innovation from concept to commercialization, offering expertise in regulatory strategy, clinical trial design and execution, market access, and post-market optimization. Our teams combine deep therapeutic knowledge with advanced data and technology to help clients make smarter decisions and thrive in the market. Join our team to help shape the future of MedTech.

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

• Bachelor's Degree Degree in scientific discipline or health care preferred. Req
• Requires at least 1 year of on-site monitoring experience. Req
• Equivalent combination of education, training and experience may be accepted in lieu of degree. Req
• 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 $90,200.00 - $150,400.00. 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.