RQM+
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
Senior Clinical Research Associate
November 6
RQM+
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. • With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. • RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies. • The Sr. CRA is responsible for aiding the team members with administrative, logistical, and practical issues, including the tracking, collection, distribution and filing study documentation. • The position is responsible for tracking and supervising the collection of ongoing study data for the purpose of regular project status reporting as required.
Requirements
• Bachelor's Degree in scientific discipline or health care preferred. • Requires at least 4 years of year of on-site monitoring experience. • 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. • ICU/CCU nursing background. • CKRT/CRRT experience is desirable. • Computer skills including proficiency in 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 co-workers, managers, sponsor staff and sites
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