Clinical Research Associate

November 6

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RQM+

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Regulatory for Medical Device • Quality Systems for Medical Device • Design Assurance for Medical Device • Product Quality for Medical Device • Post-Market Surveillance for Medical Device

501 - 1000

Description

• RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. • Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. • The Clinical Research Associate (CRA) participates in the preparation and execution of pre-market to post market clinical trials. • Oversees the progress of clinical investigations by conducting site qualification, initiation, and interim close out visits to clinical sites. • Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by RQM+ and sponsors. • Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA to ensure all monitoring activities are conducted according to study requirements.

Requirements

• Bachelor's Degree in scientific discipline or health care preferred. • Requires at least 2 years of year of on-site monitoring experience. • 2-3 years in-house or remote monitoring experience • Medical Device clinical trials experience is highly desirable • Equivalent combination of education, training and experience considered • In-depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. MedTech regulations and active experience preferred. • Strong therapeutic and protocol knowledge as provided in company training. • Computer skills including proficiency in the use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and mobile technology required. • Written and verbal communication skills including command of English language. • Organizational and pragmatic problem-solving skills • Effective time and financial management skills • Ability to establish and maintain effective working relationships with coworkers, managers, sponsor staff and sites. • Ability to travel up to 50%