Sr. Clinical Research Associate

Labcorp•Durham, NC

10d•Onsite

About The Position

This role will support a growing portfolio of oncology research initiatives, with a focus on observational clinical validity studies in minimal residual disease (MRD), alongside investigator-initiated studies, registries, and clinical utility programs. This role will support end-to-end study execution, ensuring high-quality, compliant conduct and maintaining data and biospecimen integrity, with a strong emphasis on data-sample concordance in biomarker-driven research. The Sr. Clinical Research Associate will serve as a key operational partner, acting as the primary point of contact for assigned external study sites, investigators, and collaborators while supporting cross-functional alignment internally and partnering closely with data management to deliver robust datasets that support high-impact scientific outputs and precision oncology evidence generation.

Requirements

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.
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.

Nice To Haves

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.

Responsibilities

Serve as the primary operational contact for external study sites, investigators, and collaborators, proactively managing site engagement, performance, and issue resolution across observational and non-interventional research studies.
Oversee study execution to ensure adherence to protocols, study plans, and applicable regulatory and ethical requirements (including human subjects research protections).
Conduct remote monitoring activities appropriate for observational studies, 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; partner with cross-functional teams to implement corrective and preventive actions.
Support study startup activities, including site feasibility, onboarding, and activation of external collaborators, with emphasis on data and biospecimen collection capabilities.
Lead cross-functional coordination across clinical, laboratory operations, medical, research, bioinformatics, and data management teams to ensure alignment on study timelines, deliverables, and milestones.
Contribute to the development and operationalization of study protocols, statistical analysis plans (as applicable), and data and biospecimen collection workflows.
Oversee biospecimen lifecycle management, including tracking, shipment, receipt, and documentation, ensuring chain of custody, traceability, and protocol compliance.
Ensure integrity and alignment across biospecimens, clinical data, and associated metadata, with a strong focus on data–sample concordance critical to MRD and biomarker-driven studies.
Coordinate secure data and metadata transfers (e.g., IMS, secure portals, cloud-based systems), ensuring completeness, accuracy, and proper documentation.
Monitor study progress, including enrollment, sample accrual, and site performance metrics, proactively identifying risks to data quality, completeness, and timelines.
Maintain study documentation, including study files, trackers, communication logs, and applicable regulatory documentation.
Organize and lead project meetings, investigator calls, and cross-functional updates; document and track action items and follow-ups.
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 across the oncology evidence generation portfolio.
Take ownership of assigned studies, driving end-to-end execution, operational performance, and proactively managing risks related to data quality, sample integrity, timelines, and stakeholder expectations.