Sr. Clinical Research Associate (Netherlands)

<p> At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.</p><p></p><p>We are looking for a Sr. Clinical Research Associate (Sr. CRA) to join our A-team (hybrid*/remote). As a Sr. CRA at Allucent, you will independently control and monitor investigational sites, pro-actively detect issues, provide solutions to ensure clinical studies are performed according to the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice.</p><p> </p><p><strong>In this role your key tasks will include:</strong></p><ul> <li> Governs highest possible quality standards for trial monitoring activities. </li> <li>Conducts all study tasks in compliance with quality, while preserving efficiency and in alignment to the scope of services and budgeted hours.  </li> <li>Monitors activities at clinical study sites to assure adherence to protocol, Monitoring Plan, ICH, GCP, SOPs, and applicable regulations and guidelines: </li> <li>Performs efficient site management in line with study budget.  </li> <li>Prepares and submits quality Site Visits Reports and Contact reports. </li> <li>Maintains and updates CTMS in compliance with SOPs and study-specific directives. </li> <li>Acts as Document Owner for collected documents. </li> <li>Conducts co-monitoring as needed. </li> <li>Provides functional assistance to the project team members with administrative, logistical, and practical issues, including the tracking, collection, distribution and filing study documentation (CTMS, TMF). </li> <li>Liaises with project team members and Sponsor to track study progress and milestones. </li> <li>Tracks and supervises collection of ongoing study data for purpose of regular project status reporting within agreed timelines. </li> <li>May review essential documents (GLP) as a 2nd line or Independent Reviewer (IR).  </li> <li>May participate in organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project specific CRA training. </li> <li>May perform assessment visits. </li> <li>Represents Allucent in the global medical research community, develop and maintain collaborative relationships with investigational sites and sponsor company personnel. </li> <li>Identifies potential logistical/practical problems and propose solutions / contingency plans, with timeframes for resolution. </li> <li>Acts as the lead contact in case several CRAs involved for a same study in same country. </li> <li>Supervises generation of electronic tracking systems and logs to produce status updates, progress reports and general management of the clinical deliverables when needed. </li> <li>May process and track payments to the Institutional Review Boards (IRB), Ethics Committees (EC), Regulatory Authorities, Investigators and /or vendors including timely notification to finance department, as applicable. </li> <li>May participate in meetings with clients. </li> <li>May support project manager/CTL and project functional leads in the project oversight and management. </li> <li>Supports site staff in preparation for study related site audits and inspections. </li> <li>Where applicable, reports Quality Issues and supports the root cause analysis, writing of and resolution of the Corrective and Preventative Actions. </li> </ul><p><strong>Requirements</strong></p><p><strong>To be successful you will possess:</strong></p><ul> <li>At least five years clinical monitoring experience and/or relevant clinical trial experience. </li> <li>Relevant life science degree / medical / nursing background, or combination of education and experience. </li> <li>Excellent understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating Procedures.. </li> <li> Strong written and verbal communication skills including good command of English and local language.  </li> <li>Representative, outgoing and client focused.  </li> <li>Ability to work in a fast-paced challenging environment of a growing company. </li> <li>Administrative excellence   </li> <li>Proficiency with various computer applications such as Word, Excel, and PowerPoint required. </li> <li>Effective clinical monitoring skills (all kind of visits mastered): </li> <li>Demonstrated understanding of applicable medical/therapeutic area knowledge and medical terminology. </li> <li>In-depth knowledge of clinical trials and the critical elements for success in clinical trials. </li> <li>Excellent understanding of the drug development process. </li> <li>Ability to proactively identify and resolve issues in a timely manner. </li> <li>Effective oral and written and presentation communication skills, with the ability to communicate effectively with medical personnel. </li> <li>Effective organizational and time management skills. </li> <li>Ability to manag