Clinical Research Associate II - MedTech

IQVIA; Washington (District of Columbia); On-site; USD 90,000 - 150,000; Full time

Job summary

IQVIA MedTech's MCRA unit seeks a field monitor to ensure studies are conducted per protocol and regulatory requirements. You will perform site monitoring visits, manage site communications, and drive data quality across assigned sites in the United States.

You will train site staff, track enrollment, manage CRFs and data queries, and ensure TMF/ISF completeness. Collaboration with the study team is essential to deliver on project timelines and budgets.

Qualifications

• Bachelor's degree in scientific discipline or health care.
• At least 1 year of on-site monitoring experience.
• Knowledge of GCP and ICH guidelines.
• Proficient in Microsoft Word, Excel and PowerPoint.
• Strong written and verbal English communication.
• Organizational and problem-solving abilities.
• Effective time and financial management skills.
• Ability to work with coworkers, managers and clients.

Responsibilities

• Perform site monitoring visits in line with scope, GCP/ICH and regulations.
• Collaborate with sites to drive recruitment plans to support study needs.
• Administer protocol training and maintain regular communication with sites.
• Evaluate site practices for protocol compliance and escalate quality issues.
• Track regulatory submissions, enrollment, CRF completion and data queries.
• Support start-up activities as needed.
• Maintain TMF and ISF documentation per regulatory requirements.
• Draft visit reports and action letters; support project documentation.
• Coordinate with study team for project execution support.
• Assist in developing site-specific recruitment plans and, if applicable, site finances.

Skills

GCP & ICH knowledge

On-site monitoring experience

English language communication

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Regulatory knowledge

Team collaboration

Time & financial management

Education

Bachelor's Degree in scientific discipline or health care

Equivalent combination of education, training and experience

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

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.