Sr. Clinical Research Associate

The Sr. Clinical Research Associate is responsible for advanced clinical site management and monitoring across Karius clinical programs, ensuring adherence to study protocols, ICH-GCP guidelines, sponsor procedures, and applicable regulatory requirements.

Building on the full independent site ownership expected of a CRA II, the Sr. CRA manages more complex or higher-risk sites, applies advanced judgment to monitoring findings and emerging risks, and recommends corrective actions to support effective study execution. The Sr. CRA partners closely with Clinical Trial Managers and cross-functional teams and serves as a resource and mentor to less experienced Clinical Operations team members.

Primary Responsibilities:

• Independently plan, conduct, and document on-site and remote monitoring visits, including site qualification visits (SQVs), site initiation visits (SIVs), interim monitoring visits (IMVs), and closeout visits (COVs), in accordance with the Clinical Monitoring Plan, study protocols, ICH-GCP guidelines, sponsor procedures, and applicable regulatory requirements.
• Apply a risk-based monitoring approach to evaluate site performance, protocol compliance, data quality, subject safety, and documentation completeness, and determine appropriate follow-up actions.
• Conduct comprehensive source data verification (SDV) and source data review (SDR) to ensure Case Report Form (CRF) data is accurate, complete, and consistent with source documentation and the study protocol.
• Independently manage day-to-day site relationships, driving enrollment momentum, query resolution, protocol compliance, timely completion of study activities, and overall site performance.
• Proactively identify, assess, and document monitoring findings, site-level risks, protocol deviations, compliance concerns, and data trends, and escalate significant or recurring issues with recommended corrective actions.
• Prepare and submit timely, high-quality monitoring visit reports and follow-up correspondence that clearly document site health, compliance status, findings, risks, required actions, and follow-up expectations.
• Track monitoring findings and action items through resolution and verify completion and effectiveness during subsequent monitoring contacts.
• Oversee the collection, review, and maintenance of essential regulatory and study documents to support ongoing inspection readiness.
• Support and lead site-level study start-up activities, including site qualification, readiness assessments, SIVs, regulatory document collection, and site activation requirements.
• Support and lead site-level closeout activities, including COVs, resolution of outstanding queries and monitoring findings, reconciliation activities, and completion of required site documentation.
• Collaborate closely with Clinical Trial Managers and cross-functional partners to provide site-level monitoring insights, risk assessments, and recommendations that inform study planning and operational decision-making.
• Mentor junior CRAs and CTAs on monitoring standards, visit preparation and execution, documentation practices, site management, and issue resolution.
• Monitor subject safety throughout the study, including timely review and assessment of adverse events (AEs) and serious adverse events (SAEs), and promptly escalate safety signals or reporting concerns in accordance with sponsor and regulatory requirements.
• Develop, track, and confirm implementation of corrective and preventive action plans (CAPAs) with investigative sites following protocol deviations, compliance concerns, or recurring performance issues, and verify effectiveness during subsequent monitoring visits.
• Evaluate and maintain Investigator Site Files (ISFs) and Trial Master File (TMF) documentation in accordance with sponsor SOPs, the TMF Reference Model, and study requirements, proactively identifying and resolving documentation gaps.
• Facilitate and support site staff training and retraining on protocol requirements, eClinical systems, specimen collection and handling, and study-specific procedures throughout study conduct.

Travel: Travel required up to 80%.

Position Requirements:

• A 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 studies for diagnostics, in vitro diagnostics (IVD), or regulated medical device products; familiarity with FDA device regulatory pathways strongly preferred.
• Strong working knowledge of ICH-GCP E6(R2) guidelines, FDA regulations, including 21 CFR Parts 11, 50, 54, 56, 312, and 812, and applicable local requirements governing clinical research.
• Familiarity with risk-based monitoring (RBM) frameworks and central monitoring methodologies.
• Demonstrated ability to independently manage a portfolio of investigative sites, including enrollment tracking, query management, protocol deviation documentation, monitoring follow-up, and appropriate escalation of site-level risks.
• Proficiency with electronic data capture (EDC) systems, such as iMediNet, Medidata Rave, Oracle InForm, or Veeva Vault EDC; clinical trial management systems (CTMS); and eTMF platforms, such as Veeva Vault TMF or Complion.
• Proficiency with Microsoft Office Suite and Google Workspace, including Docs, Sheets, Slides, Gmail, and Drive.
• Demonstrated experience preparing clear, accurate, and high-quality monitoring visit reports with actionable findings and follow-up requirements.
• Strong written and verbal communication skills, including the ability to prepare concise monitoring reports, professional site correspondence, and clear study updates.
• Demonstrated ability to build and sustain effective working relationships with investigative sites, Clinical Trial Managers, and cross-functional stakeholders.
• Excellent organizational and time management skills, with the ability to manage a high-volume site portfolio, prioritize competing demands, and meet study timelines.
• Ability to exercise sound judgment, independently resolve complex site-level issues, and escalate significant concerns with recommended corrective actions.
• Ability to travel up to 80% of the time, including travel on short notice, and independently manage travel logistics.
• ACRP Certified Clinical Research Associate (CCRA) or SoCRA Certified Clinical Research Professional (CCRP) certification preferred.
• Experience mentoring or training junior CRAs on monitoring practices, documentation standards, and site management techniques preferred.
• Familiarity with laboratory-developed test (LDT) and CLIA regulatory frameworks preferred.

Personal Qualifications:

• Excellent communication and interpersonal skills with the ability to build trusted relationships with investigative sites and internal stakeholders.
• Strong attention to detail, organization, and accountability.
• Advanced problem-solving skills with the ability to assess issues and recommend practical solutions.
• Ability to exercise sound judgment and work independently in complex or ambiguous situations.
• Proactive approach to identifying risks, resolving issues, and escalating with recommendations.
• Collaborative team player who mentors others and contributes to consistent, high-quality study execution.