Clinical Research Associate II - MedTech

IQVIA; United States; Sur place; USD 65 000 - 90 000; Plein temps

Résumé du poste

MCRA, LLC, part of IQVIA MedTech, seeks an experienced Clinical Research Monitor to ensure sites conduct studies per protocol, GCP and ICH guidelines. You will manage site visits, coordinate training, and track regulatory submissions while supporting subject recruitment and data integrity.

The role emphasizes collaboration with study teams to ensure quality, timely data, and compliance across sites and vendors. Experience with clinical trials is preferred.

Qualifications

• Bachelor's Degree in a scientific discipline or healthcare preferred.
• At least 1 year of on-site monitoring experience.
• Good knowledge of GCP and ICH guidelines.
• Proficient in Word, Excel, PowerPoint; laptop and mobile devices usage.

Responsabilités

• Perform site monitoring visits in accordance with GCP/ICH guidelines.
• Drive and track subject recruitment plan.
• Administer protocol training and maintain site communication.
• Evaluate site practices for protocol compliance; escalate issues.
• Track regulatory submissions, recruitment, CRF completion and data queries; support start-up.
• Maintain Trial Master File and Investigator's Site File per regulatory requirements.
• Document visit findings and action plans; generate follow-up letters.

Connaissances

Communication skills

Organizational skills

Time management

Financial management

English proficiency

Formation

Bachelor's degree in scientific discipline or healthcare

Outils

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Description du poste

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.

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.

MCRA, LLC is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.