Senior Clinical Research Associate — Remote & Multisite

StartX; Redwood City (CA); Remote; USD 92,000 - 138,000; Full time

Job summary

Karius is seeking a Sr. Clinical Research Associate to lead advanced clinical site monitoring across programs, ensuring adherence to ICH-GCP and regulatory requirements. You will mentor junior team members, manage complex sites, and collaborate with trial managers to optimize study execution.

Responsibilities include planning visits, SDV/SDR, CAPA development, and inspection readiness, with travel up to 80% and a focus on high-quality monitoring deliverables.

Qualifications

• Bachelor's degree in a life sciences or health-related field, or equivalent combination of education and experience.
• 5-8 years of clinical monitoring experience, including independent on-site and remote monitoring across multi-site studies.
• Experience monitoring diagnostics, in vitro diagnostics (IVD), or regulated medical device products; FDA pathways knowledge preferred.
• Strong working knowledge of ICH-GCP E6(R2) guidelines, FDA regulations including 21 CFR Parts 11, 50, 54, 56, 312, and 812.
• Familiarity with risk-based monitoring (RBM) frameworks and central monitoring methodologies.
• Demonstrated ability to independently manage a portfolio of investigative sites, enrollment tracking, query management, protocol deviation documentation, monitoring follow-up, and escalation of site-level risks.
• Proficiency with ED C systems (e.g., iMediNet, Medidata Rave, Oracle InForm, Veeva Vault EDC), CTMS, and eTMF platforms (Veeva Vault TMF or Complion).

Responsibilities

• Plan, conduct, and document on-site and remote monitoring visits (SQVs, SIVs, IMVs, COVs) per plan and regulatory requirements.
• Apply a risk-based monitoring approach to evaluate site performance, protocol compliance, data quality, and subject safety.
• Conduct SDV and SDR to ensure CRF data accuracy and consistency with source.
• Independently manage day-to-day site relationships, drive enrollment momentum, and resolve queries.
• Identify, assess, and document monitoring findings, site risks, deviations, and CAPA opportunities.
• Prepare and submit monitoring visit reports and follow-up correspondence with clear action plans.
• Track findings and actions through resolution and verify effectiveness in future visits.
• Oversee collection and maintenance of essential regulatory and study documents for inspection readiness.
• Support site start-up activities (SQ, SIVs, regulatory doc collection, site activation).
• Support site closeout activities (COVs, reconciliations, documentation completion).
• Collaborate with Clinical Trial Managers and cross-functional teams to inform study planning.
• Mentor junior CRAs and CTAs on monitoring standards and documentation practices.
• Monitor subject safety and escalate adverse events per sponsor and regulatory requirements.
• Develop CAPAs with sites following deviations and verify effectiveness.
• Maintain Investigator Site Files and TMF per sponsor SOPs and TMF model.
• Facilitate site staff training on protocol requirements and eClinical systems.

Skills

Site monitoring

On-site & remote monitoring

RBM familiarity

EDC/CTMS tools

Education

Bachelor's degree in life sciences or health-related field

Tools

iMediNet

Medidata Rave

Oracle InForm

Veeva Vault EDC

CTMS

TMF platforms (Veeva Vault TMF / Complion)

MS Office / Google Workspace

Job description

Karius is seeking a Sr. Clinical Research Associate to lead advanced clinical site monitoring across programs, ensuring adherence to ICH-GCP and regulatory requirements. You will mentor junior team members, manage complex sites, and collaborate with trial managers to optimize study execution.

Responsibilities include planning visits, SDV/SDR, CAPA development, and inspection readiness, with travel up to 80% and a focus on high-quality monitoring deliverables.