Job Description

Work Schedule Second Shift (Afternoons)
Environmental Conditions Office

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 a buddy 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 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/clienst, 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 documentssent 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.

Qualifications:

• Bachelor's 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 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 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

Skills Required