RQM+ is the largest global MedTech CRO, offering consulting, clinical trial, lab and reimbursement services across the entire product lifecycle. We accelerate the success of medical device, IVD, and combination product companies by providing industry-leading regulatory and quality consulting solutions. We exist to promote economic growth through regional partnerships, provide a rewarding place to work, and improve our communities.
Clinical Research Associate
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.
Key Responsibilities
- 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 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 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.
Key Requirements
- 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 clinical research experience in clinical research, medical device or CRO industries will be considered.
- Good understanding of ICH-GCP guidelines, including a basic understanding of regulatory requirements and clinical trial process.
- Ideally will have a good knowledge of ISO 14155
- Knowledge of medical terminology, clinical research acronyms and medical / scientific abbreviations.
- Ability to perform clinical data review of source documents and case report forms independently and accurately
- Able to follow study specific guidelines, plans, manuals and participate in all aspects of training in addition to performing verification and resolution of data queries / discrepancies within defined timelines
- Understanding and following oral and written instructions precisely
- Solid communication skills with co-workers, investigative site and sponsor / vendor required
- Working in a fast-paced environment and adapt easily to changing priorities
- Good knowledge in English (writing, reading, speaking)
- Ability to read and interpret study protocols, investigator brochures, study manuals and ancillary documents such as SOPs and equipment and laboratory procedure manuals
- Process the ability to write routine reports and correspondence, to speak effectively before groups of customers or at sites
- Applying common sense understanding to carry out instructions furnished in written, oral or diagram form
- Process the ability to deal with problems involving several concrete variables in standardized situations
- Good knowledge in the current Microsoft Office Suite
- Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in product and services
- Acting with customers in mind, establishing and maintaining effective relationships with customers and gains their trust and respect
- Ability to travel (approx. 60-70%)
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!