Sr. Clinical Research Associate (France)

<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>Provide functional assistance to the project team members with administrative, logistical and practical issues, including the tracking, collection, distribution and filing study documentation.</li> <li>Track and supervise collection of ongoing study data for purpose of regular project status reporting as required.</li> <li>Assist the Clinical Operations Manager in conducting feasibility assessment for potential studies. </li> <li>Govern minimum quality standards for trial monitoring activities, with respect to documentation, punctuality of reporting, compliance with objectives, and co-operation with other project team members. Ensure adequate tracking is in place for all activities and reports formatted as required for submission within agreed timelines.</li> <li>Monitor activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.</li> <li>Collect and review regulatory documents as required.</li> <li>Prepare site visit and telephone reports.</li> <li>Responsible for multiple projects and must work both independently and in a team environment.</li> <li>May participate in the study development and start-up process including reviewing protocols, drafting of the Monitoring Plan, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training.</li> <li>Resolve site issues and determine status for IP shipment.</li> <li>Work with Project Manager (PM), Clinical Team Leader (CTL) and/or Lead Clinical Research Associate (LCRA), regulatory team members or Sponsor to secure authorization of regulatory documents and contracts.</li> <li>May translate, coordinate translations or review completed translations of critical documents.</li> <li>Participate in feasibility and/or site identification activities.</li> <li>Assist the Project Team with the day-to-day management of clinical studies as required.</li> <li>Monitoring Visit Report (MVR) review, management, resolution and escalation as required.</li> <li>Train, mentor and/or supervise junior staff.</li> <li>May be assigned as LCRA to a regional or global study.</li> <li>May be assigned as a reviewer of essential documents (GLP) as a 2nd line or Independent Reviewer (IR).</li> <li>Conducts project co-monitoring, assessment visits and team training.</li> <li>Site contact for protocol clarifications and subject enrolment if CRA unavailable.</li> <li>Participate in the development of study newsletters communication as required.</li> <li>Assist with the development of project-specific training materials for team.</li> <li>Liaise with Business Development and make presentations to potential clients as required.</li> <li>May be required to manage the preparation of local clinical trial applications (for regulatory submissions for new drugs, biologics, or devices).</li> </ul><p><strong>Requirements</strong></p><p><strong>To be successful you will possess:</strong></p><ul> <li>At least 5 years monitoring experience. </li> <li>Skills to mentor and train other CRAs in a positive and effective manner.</li> <li>In-depth knowledge of clinical trials and the critical elements for success in clinical trials.</li> <li>Ability to travel for up to 8 days on site per month, depending on the project needs.</li> <li>Strong therapeutic background.</li> <li>Has shown ability to successfully manage people/project issues.</li> <li>Mature management skills demonstrated by calm and thorough review of situations. Proactively identifies and addresses problems. Seeks to understand all contributing factors. Proposes, implements, and evaluates appropriate resolutions.</li> <li>Demonstrates the ability to define and meet project requirements.</li> <li>Can demonstrate flexibility for improvement and creating solutions.</li> <li>Proven organizational abilities, and excellent written and oral communication and presentation skills.</li> <li>Excellent team player with team building skills.</li> <li>Strong customer focus.</li> <li>A thorough knowledge of regulatory submission and reporting requirements and guidelines.</li> <li>Excellent understanding of the drug development process.</li> </ul