Clinical Research Associate (Germany

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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.

The Clinical Research Associate (CRA) participates in the preparation and execution of pre-market to post-market clinical investigations. Oversees the progress of clinical investigations by conducting site qualification, initiation, interim monitoring and close out visits to clinical sites. Monitors clinical investigations in accordance with Good Clinical Practice/ISO 14155 and procedures set forth by RQM+ and sponsors. Works closely with the Project Manager and/or Lead CRA to ensure all monitoring activities are conducted according to study requirements.

• Participates in the investigator recruitment process and performs site qualification visits of potential investigators.
• Evaluates the capability of the site to successfully manage and conduct clinical studies.
• Collaborates with the start-up department to coordinate activities with the site in preparation for the initiation of the study.
• Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical investigations.
• Works with start-up, project team and site staff to obtain regulatory (IRB/IEC/CA) approval of study specific documents.
• Performs site initiation activities, reviewing with the site personnel the clinical investigation plan, regulatory status, study procedures, and provides training on completion of the eCRF, monitoring activities and study close-out activities.
• Trains site staff on the EDC system and verifies site computer system.
• Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISS.
• Assures adherence to Good Clinical Practice/ISO 14155, 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 clinical investigation materials as required by sponsor.
• Performs investigational or commercial product inventory and accountability (as applicable)
• 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 source data verification.
• Works with sites to resolve data queries.
• May review clinical investigation plans, eCRFs, study manuals and other related documents, as requested by the Project Manager and/or Lead CRA.
• 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 and the preparation of the monitoring manual
• 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 study 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.
• Performs other duties, as requested.

• University / College degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing, certification, medical or laboratory technology), or equivalent combination of education and experience.
• In lieu of the above requirement, candidates with some years of relevant…