Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Summary of Essential Functions:
· Performs file reviews and documents findings in appropriate system, including supervising local regulatory documents.
· Supports maintenance of study-specific documentation and global systems/tools.
· Analyzes and reconciles study metrics and findings reports, clarifying and resolving issues related to site documentation.
· May support study-specific translation of materials and QC.
· Ensures efficient site contact and follow-up plan, bringing up concerns as needed.
· May work with the CTT Representative, to provide relevant study information
· May conduct quarterly eTMF completeness checks.
In addition to tasks listed above essential functions will include tasks below with increased skill level and years of experience above the CTC II.
· Provides admin and technical support to study management and program teams, including:
o Supports meeting scheduling, minute taking, document creation and transmission.
o May maintain vendor trackers.
o Works with sites to acquire relevant documents.
o Completes site interest plan and documents site communications.
o Works directly with sites to acquire site qualification, selection and start-up documents.
o Works with the CSO function to develop the site list and ensures contact details are maintained in systems including Veeva.
· Performs document processing and follow-up tasks, including:
o Initial quality checks of eTMF documents, file reviews, and documents findings.
o Request eTraining report reviews to begin on a quarterly basis
· Coordinates and completes assigned activities ensuring proactive scheduling and fulfillment, aligned with project team needs, including:
o Provides system access (e.g., Veeva & eTMF) and inputting site and study information into current databases and generating reports.
o Analyzes and reconciles study metrics and findings reports.
o Assists with coordination, compilation, and distribution of Investigator Site File (ISF) and supplies to sites.
o May maintain vendor trackers.
· Assists with Study Start-up and ongoing submission activities as needed
o Transmits documents to centralized IRB/IEC (on-going).
o Request insurance in each country
o Coordinates with key QSDO functions to align site start-up activities.
o Coordinates the translation of study documents
o May be requested to help with checking if CDAs exist/are expired & acquiring a new Inv/Institution CDA.
· Other crucial tasks and principal duties:
o Supports survey data review and collaboration with teammates.
o May liaise and chips in to feasibility processes.
o Aligned with general and study specific training, ensuring knowledge of relevant SOPs and regulatory guidance.
o Chips in to the development of guidelines.
Education and Experience:
• Bachelor's degree/previous experience comparable to 3 to 5 years