Clinical Trial Coordinator
<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>Join Us as a 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+ 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'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 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 & 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 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>
