Has anyone made the jump from regulatory affairs into a CRA or SSU role? I’ve led 1572/IB updates and TMF QC in Veeva Vault for two Phase II studies last year, and I’m meticulous about audit trails and version control, but I’m unsure how to frame that for hiring managers or what hands-on EDC experience (e.g., Rave) is most credible to pursue first.
Quantify TMF QC (e.g., 0% overdue essential docs); take Rave Essentials: https://www.medidata.com/en/academy/.
Quick win: ask to shadow one SIV and draft the follow-up letter plus pre-SIV TMF/ISF reconciliation; on your resume, frame it as “reduced greenlight defects and cut site-activation cycle time by X days.” @robert_w79’s Rave tip is solid, but if access is tricky, own the greenlight package checklist and track time-to-SIV — it’s translating fluent regulatory into site activation. Would your manager let you trial that on the next start-up wave?