Clinical Trial Coordinator/ Client dedicated

<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/Senior 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&#43; 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 Senior Clinical Trial Coordinator, you&#39;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 (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 organization/vendor/clients, 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 &amp; 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&#39;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 non-clinical/clinical 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>