Senior Clinical Research Associate – Phase 1 & Data Readiness

San Diego, United States | Posted on 09/23/2026

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, elevate, 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.