Senior Clinical Research Associate

Essential Functions and Responsibilities:

• Independently manages the study start up activities for multi-center, US and/or global based studies.
• Performs on-site visits (feasibility, SIV, IMV, Close-Out) with CRO CRAs as needed to assess the sites’ and CRA’s overall performance.
• Provides monitoring oversight by reviewing monitoring schedules, metrics and reports.

Travel:

• Ability to travel up to 25%.

Required Education, Skills, and Knowledge:

• BS/BA, RN, or equivalent with at least 4 years of clinical trial monitoring / clinical trial management and vendor experience.
• 8+ years of clinical operations experience.
• Must have strong knowledge of ICH/GCP guidelines and protocol and clinical drug development processes.

Physical Demands:

• Must be able to remain in a stationary position standing or sitting for prolonged periods.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally.
• Must have visual acuity to perform activities such as preparing and analyzing data and figures.