Sr. Clinical Trial Associate

3 days/week in-office required (onsite T/W/Th, remote M/F)

The Sr. Clinical Trial Associate will assist the Study Lead by coordinating various administrative aspects of the project management and oversight activities. Will support the study lead with study start-up activities, tracking study progress, overseeing the trial master file quality and completeness, maintaining meeting agendas and minutes, and implementing learnings/sharing knowledge with other study management teams.

Support the Study Management Teams with the following:

• Study start-up activities.
• Site and vendor management.
• Writing and distributing meeting agendas and meeting minutes.
• Organizing and planning meetings (e.g. agendas, minutes, rooms, participants).
• Creating and managing trackers and logs for oversight of clinical trials.
• Ensure a high-quality filing structure and archival of trial documents.
• Oversight, maintenance, and regular checks of trial master file (TMF).

• 4+ years’ experience as a Clinical Trial Associate (or similar)
• Experience reviewing TMF documentation for accuracy and completeness
• Experience creating and maintaining study trackers, tools, and reports
• Basic knowledge of clinical trial processes and ICH/GCP guidelines
• Knowledge of DIA TMF Reference Model
• Rare Disease domain knowledge preferred
• Strong organization and time management skills
• Excellent written and verbal communication skills

• Bachelor’s degree in a relevant field preferred (Biology, Health Care, Life Sciences, etc.)