Study Start-Up Associate

Job Summary

Working remotely in a full-time capacity, the Study Start-Up Associate II will provide administrative support for regulatory submission packages related to international clinical trials, manage study timelines, and coordinate communication with cross-functional teams.

Key responsibilities

• Creates MS project files to establish study start-up timelines and processes for each country
• Tracks and follows up on missing documents and prepares submissions to Regulatory Authorities and IEC/IRB
• Maintains accurate tracking of site status and coordinates with study team members for essential document collection

Required qualifications

• Bachelor's degree in Life Sciences, Health Sciences, Nursing, or a related field required
• 1 to 3 years of experience in pharma and/or CRO, with a focus on study start-up activities preferred
• Knowledge of clinical research processes related to study start-up and medical terminology
• Working knowledge of MS Project, Word, and Excel is required
• Master's Degree (MS, MPH, PharmD) is preferred