5-7 years of CRA/clinical monitoring experience; 7-10+ years preferred.
Proven ability to work independently with minimal onboarding.
Recent hands-on onsite monitoring and source data verification experience.
Strong background in data cleaning and database-lock readiness.
Proficient in Veeva Vault and Medidata Rave.
Experience with routine monitoring activities and regulatory compliance.
Bachelor's degree in a relevant field preferred; equivalent experience considered.
Responsibilities
Assume independent clinical monitoring for an active Phase 1 study.
Conduct onsite and remote monitoring focusing on source data verification and regulatory documentation.
Identify and resolve data-readiness gaps before database lock milestones.
Document monitoring activities in Veeva Vault and Medidata Rave.
Review regulatory binders and ensure documentation is inspection-ready.
Escalate and follow through on protocol deviations and compliance concerns.
Collaborate with Senior CRAs and Clinical Trial Management while managing assigned tasks independently.
Benefits
W2 employment only (no C2C/1099).
Full-time, 40-hour work week.
Frequent travel to clinical research sites with reimbursed expenses.
Opportunity to support a cutting-edge early-phase clinical program.
Potential for assignment extension based on study needs.
Full 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.
Requirements
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.
