Senior Clinical Research Associate - Phase 1 & Data Readiness 3677938

Job Description

Job Description

Be Part Of A Dynamic Team

Join a clinical operations organization supporting innovative therapies for patients with serious and rare diseases. This opportunity is embedded within an active early-phase clinical program approaching a critical data milestone. The clinical operations team works directly with investigative sites and cross-functional partners to ensure clinical data, regulatory documentation, and monitoring activities are complete, accurate, and inspection-ready.

The selected Senior CRA will join an established study team during an important period leading into database lock and provide immediate hands-on support where monitoring and data-readiness capacity is needed most.

What's In Store For You

• Engagement: W2 only (no C2C/1099)
• Full-time, 40-hour-per-week assignment.
• U.S.-based opportunity with frequent travel to clinical research sites.
• Travel expenses associated with study monitoring are reimbursed.
• Opportunity to support a cutting-edge early-phase rare-disease clinical program.
• Work alongside experienced Senior CRAs, Clinical Trial Management, Data Management, and Clinical Operations leadership.
• Although initially structured as a short-term assignment, potential extension may be considered based on ongoing study needs.

How You Will Make An Impact

• Immediately assume independent clinical monitoring activities for an active Phase 1 study approaching database lock.
• Conduct onsite and remote monitoring with an emphasis on source data verification, source review, regulatory documentation, and outstanding query resolution.
• Identify and resolve data-readiness gaps ahead of study data-cutoff and database-lock milestones.
• Work directly within Veeva Vault and Medidata Rave to document monitoring activities, review clinical data, and follow outstanding actions through completion.
• Perform regulatory binder and essential-document review and help ensure documentation is complete and inspection-ready.
• Identify, document, escalate, and follow through on protocol deviations, data discrepancies, compliance concerns, and other site issues.
• Partner closely with existing Senior CRAs, Clinical Trial Management, and Data Management while independently owning assigned work.
• Travel frequently to investigative sites when source documentation or regulatory records require onsite review.
• Provide clear, timely monitoring documentation and action-item follow-up without requiring significant day-to-day oversight.

Do You Bring Proven Success In Independent Early-Phase Clinical Monitoring?

• Minimum 5 years of CRA/clinical monitoring experience , with approximately 7–10+ years strongly desirable for this senior-level assignment.
• Demonstrated ability to work independently as an experienced CRA with minimal onboarding.
• Recent hands-on onsite monitoring and SDV/SDR experience.
• Strong experience supporting data cleaning, data cutoff, interim freeze, or database-lock readiness.
• Hands-on proficiency with Veeva Vault , including monitoring-related CTMS/eTMF workflows.
• Hands-on proficiency with Medidata Rave .
• Experience conducting routine monitoring activities including SIVs, IMVs, COVs, and related site follow-up.
• Experience reviewing regulatory binders, essential documents, protocol deviations, queries, and site-level compliance issues.
• Phase 1 or similarly complex early-phase clinical research experience strongly preferred.
• Gene therapy and/or rare-disease experience strongly preferred but not mandatory.
• First-in-human clinical trial exposure is highly desirable.
• Prior sponsor-side clinical operations experience is beneficial but not required.
• Strong written communication, monitoring-report documentation, prioritization, and issue-resolution skills.
• Ability to travel approximately 75% during the assignment.
• Bachelor's degree in a relevant discipline preferred; equivalent education and relevant clinical research experience may be considered.
• ACRP or SOCRA certification is preferred but not required.