Sr. Clinical Research Associate

Job Summary

This role supports a growing portfolio of oncology research initiatives, focusing on observational clinical validity studies in minimal residual disease (MRD), investigator-initiated studies, registries, and clinical utility programs. Key responsibilities include:

• Serve as the primary operational contact for external study sites, investigators, and collaborators.
• Oversee study execution to ensure adherence to protocols, study plans, and regulatory requirements.
• Conduct remote monitoring activities, including review of study documentation, data quality checks, and verification of protocol and data collection adherence.
• Identify, document, and escalate protocol deviations, data discrepancies, and compliance risks.
• Support study startup activities, including site feasibility, onboarding, and activation of external collaborators.
• Lead cross-functional coordination across clinical, laboratory operations, medical, research, bioinformatics, and data management teams.
• Contribute to the development and operationalization of study protocols, statistical analysis plans, and data and biospecimen collection workflows.
• Oversee biospecimen lifecycle management, ensuring integrity and alignment across biospecimens, clinical data, and associated metadata.
• Coordinate secure data and metadata transfers, ensuring completeness, accuracy, and proper documentation.
• Maintain study documentation, including study files, trackers, communication logs, and applicable regulatory documentation.
• Organize and lead project meetings, investigator calls, and cross-functional updates.
• Support IRB submissions, protocol amendments, and regulatory documentation to ensure ongoing compliance.
• Collaborate with data management and analytics teams to support data quality review, query resolution, and reporting/dashboard development.
• Identify workflow gaps and drive process improvements to enhance consistency, scalability, and operational excellence.

Job Responsibilities

Key responsibilities include:

• Manage site engagement, performance, and issue resolution for observational and non-interventional research studies.
• Ensure adherence to protocols, study plans, and regulatory requirements.
• Conduct remote monitoring activities, including review of study documentation, data quality checks, and verification of protocol and data collection adherence.
• Document and escalate protocol deviations, data discrepancies, and compliance risks.
• Support study startup activities, including site feasibility, onboarding, and activation of external collaborators.
• Collaborate with cross-functional teams to ensure alignment on study timelines, deliverables, and milestones.
• Develop and operationalize study protocols, statistical analysis plans, and data and biospecimen collection workflows.
• Oversee biospecimen lifecycle management, ensuring integrity and alignment across biospecimens, clinical data, and associated metadata.
• Coordinate secure data and metadata transfers, ensuring completeness, accuracy, and proper documentation.
• Maintain study documentation, including study files, trackers, communication logs, and applicable regulatory documentation.
• Organize and lead project meetings, investigator calls, and cross-functional updates.
• Support IRB submissions, protocol amendments, and regulatory documentation to ensure ongoing compliance.
• Collaborate with data management and analytics teams to support data quality review, query resolution, and reporting/dashboard development.
• Identify workflow gaps and drive process improvements to enhance consistency, scalability, and operational excellence.

Minimum Qualifications

• Bachelor's degree in life sciences, health sciences, nursing, or a related scientific discipline.
• 5 or more years of experience as a Clinical Research Associate (CRA) or in a comparable clinical research role.
• 3 or more years experience supporting observational and/or interventional clinical studies in industry, CRO, or academic medical center settings.

Preferred Qualifications

• Master’s degree in life sciences, health sciences, or a related scientific discipline.
• 3 or more years experience in oncology, precision medicine, molecular diagnostics, or biomarker-driven clinical research.
• 2 or more years experience with genomics, next-generation sequencing (NGS), circulating tumor DNA (ctDNA), and/or minimal residual disease (MRD) testing.
• 2 or more years experience supporting observational studies, patient registries, real-world evidence programs, or decentralized research models.
• 2 or more years experience coordinating research biospecimen collection, shipment, tracking, and reconciliation across multi-site studies.

Additional Job Standards

• Working knowledge of GCP, ICH-GCP, FDA regulations, human subjects protections, and applicable clinical research requirements.
• Demonstrated ability to manage study timelines, compliance, data quality, and competing priorities across multiple projects and study sites.
• Experience collaborating with external investigators, research partners, and cross-functional teams to support study execution.
• Strong organizational, communication, and problem-solving skills, with the ability to identify and mitigate study risks.
• Proficiency with Microsoft Office, Teams, SharePoint, Smartsheet, or similar tracking and collaboration tools.
• Experience supporting audits, inspections, regulatory activities, and data quality review processes.

Benefits

• Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan.