RQM+

Compensation

Full Description

RQM+ is The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients — faster, safer, better. We don’t make MedTech. We make MedTech happen. Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency The Safety Associate (SA) assists with successful planning, implementation, and execution of contracted safety management activities. Under the guidance of the Safety Manager, the SA is responsible for monitoring and processing Adverse Events, supporting CEC and DSMB management, assisting with applicable regulatory reporting, and serving as a resource on safety-related issues. Assures clear client and internal team communication, process documentation, and compliance with applicable US and international regulations, Good Clinical Practices and procedures set forth by RQM+ and its clients. \n Responsibilities: Exhibit subject matter expertise in clinical trial conduct and safety with a focus on medical device studies, as well as combination products and software as medical device. Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements. Gathers, reviews and interprets source documentation from clinical sites to formulate a cohesive narrative for safety events. To perform Pharmacovigilance per project requirement including but not limited to, collecting, and tracking incoming Adverse Events(AE)/endpoint information. Determine initial/update status of incoming events. Review and evaluate adverse events to determine if they meet regulatory reporting requirements. Database entry in commercial and validated safety database. Coding AEs in accordance with MedDRA and WHO Dictionary and writing case narratives, literature related activities as per internal / project timelines. Assist in development of project-specific safety management plan, safety committee charters, procedures, workflows, and templates. Safety Committee support and coordination; obtain electronic signatures, onboarding members, member management, manage and facilitate meetings, prepare materials, assist with documentation, document maintenance, and liaising with study personnel. Ensure to meet the expected productivity, quality standards and delivery standards per project requirements and department KPIs. Identify quality problems, if any, and bring them to the attention of a senior team member. Contribute to identification, development, and implementation of safety management initiatives and process improvements. Assist with risk assessment activities and implementation of effective control measures and corrective action solutions, as required. To mentor new team members, if assigned by the Sr. Manager. Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes. Collaborate with cross-functional teams to ensure compliance with regulatory requirements related to device safety and pharmacovigilance. Prioritize and complete the assigned training on time. Perform other duties as assigned. Requirements: Bachelor's degree or RN in life sciences or healthcare related field. Minimum of 3 years in related field. Minimum of 3-years direct experience in clinical studies, preferably in drug/device safety or CRA position. Equivalent combination of education, training, and experience Thorough knowledge of and experience in clinical research process from study start up through archiving of TMF, including Interim analysis and database lock Robust understanding of general anatomy, physiology and pathological processes Applicable knowledge and understanding of safety events, data queries and reporting relative to medical devices. Knowledge and understanding of global processes, regulations, and reporting requirements for medical device and pharma. Prior or current knowledge of Clinical Event Committee and Data Safety Monitoring Committee workflows. Good knowledge of medical terminology and reporting obligations. Working knowledge of applicable Safety Database and any other internal/Client applications. Knowledge of applicable global, regional, local clinical research regulatory requirements. Prior experience in electronic data capture (EDC) required. Excellent attention to detail and accuracy, maintain high quality standards. Good working knowledge of Microsoft Office, electronic signature platforms and web-based applications. Self-motivated and flexible to meet the needs of the department. Excellent organizational, time management and interpersonal skills. Ability to follow instructions/guidelines, utilize initiative and work independently. Ability to manage competing priorities and deadlines within various clinical trials. Willingness and aptitude to learn new skills across Safety service lines. Ensure quality of deliverables according to the agreed terms. Flexibility to operate in shifts. Up to 20% travel may be required including international travel Strong communication skills (verbal and written) to express complex ideas Excellent and demonstrated organizational and interpersonal skills Excellent verbal and written communication The ability to work independently, prioritize and work within a matrix team environment is essential. Working knowledge of Word, Excel, and PowerPoint required. Experience with electronic signature platforms required Ability to work in an intense, fast-paced, multinational work environment. Ability to effectively communicate with employees, colleagues, and global teams Positive motivator Internal and external customer focus and results orientation Behaviors: Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Collaboration, Compliance, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning Supervisory Responsibilities This position may have supervisory responsibilities. Work Environment/Physical Demands This job operates in a professional office environment that may be remote. This role routinely uses standard office equipment such as computers, phones, photocopiers and filing cabinets. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift or move objects up to 10 pounds and occasionally lift or move objects up to 25 pounds. \n Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today! We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us. Job Opportunity Verification At RQM+, we prioritize the security of our job applicants. To ensure a safe application process: All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers Every candidate going through the interview process will participate in a voice and/or video interview. Exercise caution with unsolicited job offers or requests for sensitive information.