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Clinical Trial Coordinator
Indeed
Full-time
Onsite
No experience limit
No degree limit
79Q22222+22
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Description

Summary: Join as a Senior Clinical Trial Coordinator, providing administrative and technical support, coordinating project activities, and acting as a cross-functional liaison. Highlights: 1. Opportunity to make an impact at the forefront of innovation 2. Coordinate and facilitate project activities as a study lead 3. Support process improvements and enhancements **Work Schedule** Standard (Mon\-Fri)**Environmental Conditions** Office**Job Description** Join Us as a Senior Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation 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. 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. What You’ll Do: * According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix. * Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system. * 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. * 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. * Provides system support (i.e. GoBalto \& eTMF). * Supports RBM activities. * 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. * Supports scheduling and organization of client and/or internal meetings with completion of related meeting minutes. * Reviews and tracks local regulatory documents. * Transmits documents to client and centralized IRB/IEC. * Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation. * Maintains vendor trackers. * Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non\-clinical study supplies to sites. * Assists with study\-specific translation materials and translation QC upon request. * May attend Kick off meeting and take notes when required. Education and Experience Requirements: * High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification. * Bachelor's degree preferred. * Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years). 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. Knowledge, Skills and Abilities: * Ability to work in a team or independently as required * Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively * Proven ability to effectively analyze project\-specific data/systems to ensure accuracy and efficiency * Strong customer focus * Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines * 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 * Excellent English language and grammar skills and proficient local language skills as needed * Good presentation skills * Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems * Ability to successfully complete PPD clinical training program * Self\-motivated, positive attitude with effective strong interpersonal skills Working Conditions and Environment: * Work is performed in an office/ laboratory/clinical/ and/or home office environment with exposure to electrical office equipment. * Occasional drives to site locations. Potential Occasional travel required

Source:  indeed View original post
Juan García
Indeed · HR

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