Senior Clinical Research Associate

Position Summary:

As an in-house Clinical Research Associate (CRA) you will work closely with the Clinical Operations team to support the full scope of study activities, including site activation, patient recruitment, study monitoring and site and vendor management. You will work cross functionally within the CymaBay team as well as with study sites, CROs and other vendors.

Responsibilities:

• Work closely with the Clinical Trial Manager to support all aspects of clinical studies
• Take a leadership role in certain site and study management activities including: ICFs, site activations, monitoring reports and study plans
• Collaborate with cross functional team members to independently address routine study issues
• Assist with CRO and/or vendor (central lab, IxRS, data management, etc) oversight and management to ensure milestones are achieved
• Identify issues for escalation, participate in problem solving and implementation of risk mitigation
• Participate in departmental and corporate initiatives
• Perform co-monitoring visits with CRO, on an as needed basis, to provide oversight during site qualification, site initiation, routine monitoring, and close-out visits
• Generate and maintain reports, listings, and trackers as needed
• Ensure close tracking of site enrollment and related metrics
• Support development and UAT of EDC, IWRS, eDiary and other systems
• Complete other responsibilities as assigned

Qualifications:

• Bachelor’s degree or equivalent training and experience (i.e., technical degree)
• Experience supporting studies in a fast-paced environment
• Success in working with CROs and vendors
• Excellent communication skills and ability to achieve milestones in a team environment
• 3+ years clinical study experience with time at a sponsor company preferred