Clinical Research Associate II

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Current job opportunities are posted here as they become available.

RQM+ is The Med Tech 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 Med Tech. We make Med Tech 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 Med Tech 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.

We are beginning the interview process now with an anticipated start date of November 2026
. Timing is subject to change based on business needs.

Looking for candidates in Chicago, IL, TX or NY

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 GCP and procedures set forth by RQM+ and sponsors. Works closely with the CTM and/or Lead CRA to ensure all monitoring activities are conducted according to study requirements.

• 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 GCP, 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

• Bachelor's Degree in scientific discipline or health care preferred.
• Requires at least 2 years of on-site monitoring experience with medical…