Site Readiness and Reg Specialist I

Develops awareness of regulatory legislation, guidance, and practice in the assigned regions/countries with the support from senior staff.

Completes the following activities for clinical trial applications performed according to European Clinical Trials Regulation No 536/2014 in the Clinical Trials Information System (CTIS) under supervision and in close collaboration with the Global Regulatory Submissions Lead (GRSL) colleagues:
Completes Part I application information in Clinical Trial Information System (CTIS)

Accurately uploads all Part I and Part II documents to CTIS
Initiates the payment process for Part I and/or Part II submission fees and seeks approval from GRSL.

Monitors CTIS and promptly informs the GRSL of all received alerts in CTIS
Ensures timely tracking of all submissions and approvals (decisions) in applicable tracking tools.

Uploads the final submitted package to the Trial Master File and performs functional reviews as applicable
Performs a review of final submission documents as applicable and specifically performs QC of Part II applications (as delegated)
Submits application/notifications in CTIS upon permission of GRSL
Ensures high quality documents are uploaded and filed, and systems are updated on an ongoing and timely basis making Fortrea ready for an audit at any time

Escalates study issues appropriately and in a timely fashion
Attends team and company meetings as applicable. Performs other duties as assigned by management depending upon country and situational requirements with proper supervision (if applicable)

Experience - 2 - 5 years of relevant experience in EU CTR and CTIS submissions

Education - Graduation / Masters in life sciences

Learn more about our EEO & Accommodations request here.