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 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 Practices/ISO 14155 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.
- 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 the clinical study.
- 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 study initiation activities, reviewing with the site personnel the clinical investigation plan, 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 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 Practices/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 Clinical Trial 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.
- 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
- Bachelor's Degree in scientific discipline or health care preferred.
- Requires at least 2 years of on-site monitoring experience.
- 2-3 years in-house or remote monitoring experience
- Equivalent combination of education, training and experience considered
- In-depth k