Clinical Trial Coordinator

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<p style="text-align:left"><b>Work Schedule</b></p>Standard (Mon-Fri)<p style="text-align:inherit"></p><p style="text-align:left"><b>Environmental Conditions</b></p>Office<p style="text-align:inherit"></p><p style="text-align:left"><b><u>Job Description</u></b></p><p style="text-align:inherit"></p><p>Join Us as a Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation<br>We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.<br><br>As part of our global team, you’ll have the opportunity to provide administrative and technical support to the Project Team. As a Clinical Trial Coordinator, you'll coordinate and facilitate project activities and may serve as a study lead, acting as a cross-functional liaison for the project team. You will act as a buddy during the onboarding phase and provide training to new staff as needed. Additionally, you will support departmental and cross-functional initiatives for process improvements and enhancements.<br><br>What You’ll Do:<br>• According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.<br>• Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.<br>• Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads and line manager as appropriate.<br>• Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers including but not limited to: study team lists, tracking of project specific training requirements, system access management for <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">organization/vendor/clients,</span> and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system.<br>• Provides system support (i.e. GoBalto & eTMF).<br>• Supports RBM activities.<br>• Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.<br>• Supports scheduling and organization of client and/or internal meetings with completion of related meeting minutes.<br>• Reviews and tracks local regulatory documents.<br>• Transmits documents to client and centralized IRB/IEC.<br>• Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.<br>• Maintains vendor trackers.<br>• Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.<br>• Assists with study-specific translation materials and translation QC upon request.<br>• May attend Kick off meeting and take notes when required.<br><br>Education and Experience Requirements:<br>• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.<br>• Bachelor's degree preferred.<br>• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years).<br>In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.<br><br>Knowledge, Skills and Abilities:<br>• Ability to work in a team or independently as required<br>• Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively<br>• Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency<br>• Strong customer focus<br>• Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines<br>• Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">non-clinical/clinical</span> aspects of project implementation, execution and closeout<br>• Excellent English language and grammar skills and proficient local language skills as needed<br>• Good presentation skills<br>• Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems<br>• Ability to successfully complete PPD clinical training program<br>• Self-motivated, positive attitude with effective strong interpersonal skills<br><br><br><br>Working Conditions and Environment:<br>• Work is performed in an office/ laboratory/clinical/ and/or home office environment with exposure to electrical office equipment.<br>• Occasional drives to site locations. Potential Occasional travel required</p><p></p><p></p><p></p><p></p>

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