Work Schedule

Second Shift (Afternoons)

Environmental Conditions

Office

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 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 roleShould have experience in Veeva Vault & CTMS toolsShould have expereince in eTMF systemShould 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