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.

Job Summary:

The Clinical Research Associate II (CRA II) 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, interim and 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.

Primary Responsibilities:

• Collaborates with the start-up department to coordinate activities with assigned sites in preparation for the initiation of the study.
• Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials.
• Works with start-up, project team and site staff to obtain regulatory (IRB/IEC) approval of study specific documents.
• Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF, monitoring activities and study close-out activities.
• Trains site staff on the EDC system.
• Assists in resolving any issues to ensure compliance with site file audits in conjunction with eTMF.
• Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits.
• Performs validation of source documentation as required by sponsor and prepares monitoring reports and letters per the timelines defined in RQM+ SOPs by using approved templates and reports.
• Documents accountability, stability and storage conditions of investigational and commercial product inventory as required by sponsor.
• Ensures return of unused study product to designated location or verifies destruction as required.
• Reviews the quality and integrity of the clinical data through in-house review of electronic CRF data and on-site or remote source verification.
• Works with sites to resolve data queries.
• Serves as primary contact between RQM+, sponsor and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
• Performs study close-out visits per the study specific Clinical Monitoring Plan including final study product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
• Assists with, and attends, Investigator Meetings for assigned studies.
• Authorized to request site audits due to data integrity concerns.
• Attends study-related, company, departmental, and external meetings, as required.
• Ensures internal and study-related trainings are completed per RQM+ process and/or study timelines, including updating the study level trial management system.
• Ensures all study deliverables are completed per RQM+ and study timelines.
• Serves as mentor for junior staff and those new to the company and/or study.
• Participate in training and mentoring new staff up to Clinical Research Associate level as appropriate
• Performs other duties, as requested

Education/Work Experience/Requirements:

• Bachelor's Degree in scientific discipline or health care preferred.
• Requires at least 2 years of on-site monitoring experience.
• In-house or remote monitoring experience preferred.
• Equivalent combination of education, training and experience considered
• In-depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Clinical Trial Regulation, Good Clinical Practice (ICH-GCP) guidelines and international standards like ISO 14155. 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 act in a lead role on a study assuming additional responsibilities as detailed/documented by the Project Manager if appropriate
• Ability to travel up to 60-75%

Behaviors: Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning

Supervisory Responsibilities: This position does not have supervisory responsibilities.

Work Environment & Physical Requirements: This role involves regular travel to client and partner sites, which may include varying office and facility environments. The employee should be able to travel independently, navigate different facility types, and occasionally lift or carry items up to 20 lbs. (e.g., equipment, materials, luggage).

These requirements reflect what's typically needed to perform the core functions of this role. If you require an accommodation to perform any aspect of this position, please let us know — we're happy to discuss options.

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.

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All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers

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