Sr Clinical Trial Coordinator / Clinical Trial Coordinator II

Work Schedule

Environmental Conditions

Job Description

Provides administrative and technical support to the Project Team. Coordinates and facilitates project activities and may serve as a study lead acting as a cross-functional liason for the project team. Acts as abuddy during onboarding phase and provides training to new staff as needed. Supports departmental and cross-functional initiatives for process improvements/enhancements.

Roles & Responsibilities

• According to the specific role (Central or Local) coordinates oversees andcompletes functions on assigned trials activities detailed on the task matrix.
• Performs department Internal Country and Investigator file reviews as assignedand documents findings in appropriate system.
• Ensures allocated tasks are performed on time within budget and to a highquality standard. Proactively communicates any risks to project leads and linemanager as appropriate.
• Supports the maintenance of study specific documentation and global supportwith specific systems tools and trackers including but not limited to: study teamlists tracking of project specific training requirements system accessmanagement for organization/vendor/clienst and tracking of project levelactivity plans in appropriate system. Ensures (e)TMF is up to date by followingfile 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 documentssent to Client (e)TMF as assigned performing(e)TMF reviews performing mass mailings and communications as neededproviding documents and reports to internal team members.
• Supports scheduling and organization of client and/or internal meetings withcompletion 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 withclarification 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.

Qualifications:

• Bachelors degree preferred.
• 4 Years of experience in Clinical Trial coordinator role
• Should have experience in Veeva Vault & CTMS tools
• Should have expereince in eTMF system
• Should have expereince in Global Clinical Trials and supporting global Project Managers
• Ability to work in a team or independently as required
• Strong organizational skills and attention to detail with proven ability to handle multiple tasksefficiently 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 meetchanging project timelines
• Demonstrated ability to attain and maintain a good working knowledge of applicable CountryRegulations ICH Good Clinical Practices and organization/Client SOPs and WPDs for all nonclinical/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