Specialist II, Study Build

• Ensures study build documents are set up in a timely manner so as to not delay study start-up.
• Follows a multi-step procedure to ensure data study build integrity.
• Can work independently day to day and does not require oversight or quality checks from those who are more senior in their current role.
• Ensures that the site-level team is aware when study build is set up and completed at the project level.
• Review and comprehend the protocol and any other supporting material or guidelines.
• Supports new sites in the process of acquisition to ensure harmonization in study build.
• Demonstrates flexibility and willingness to work in multiple systems and manage study build in multiple formats.
• Assist new hires in completing and submitting all required research documentation and training by their deadlines.
• Communicate with site-level staff regarding amendments and changes to study build.
• Communicate internally with the source team regarding source status and changes to study build.
• Adhere to safety and compliance regulations.
• Other duties as assigned. Qualifications

Required Skills/Abilities:

• Ensures study build documents are set up in a timely manner so as to not delay study start-up.
• Follows a multi-step procedure to ensure data study build integrity.
• Can work independently day to day and does not require oversight or quality checks from those who are more senior in their current role.
• Ensures that the site-level team is aware when study build is set up and completed at the project level.
• Review and comprehend the protocol and any other supporting material or guidelines.
• Supports new sites in the process of acquisition to ensure harmonization in study build.
• Demonstrates flexibility and willingness to work in multiple systems and manage study build in multiple formats.
• Assist new hires in completing and submitting all required research documentation and trainings by their deadlines.
• Communicate with site-level staff regarding amendments and changes to study build.
• Communicate internally with the source team regarding source status and changes to study build.
• Adhere to safety and compliance regulations.