Clinical Research Associate

ClinLab Solutions Group; United States; Hybrid; USD 85,000 - 120,000; Full time

Benefits offered by this job

Mentorship program

Remote monitoring opportunities

Competitive salary

Job summary

ClinLab Solutions Group seeks a Sr. Clinical Research Associate to lead advanced site management across client programs, ensuring adherence to study protocols, ICH-GCP guidelines, sponsor procedures, and regulatory requirements. The Sr.

CRA will independently plan, conduct, and document on-site and remote monitoring visits, apply risk-based monitoring, and perform SDV/SDR to maintain data integrity. This role partners with trial managers and mentors junior CRAs to ensure study success and

Qualifications

• Extensive experience in on-site and remote monitoring across clinical programs.
• Strong knowledge of ICH-GCP guidelines and regulatory requirements.
• Ability to mentor junior staff and collaborate across cross-functional teams.

Responsibilities

• Plan, conduct, and document site monitoring visits (SQVs, SIVs, IMVs, COVs).
• Apply risk-based monitoring to assess site performance and data quality.
• Conduct SDV/SDR to ensure CRF accuracy and protocol adherence.
• Manage day-to-day site relationships and drive enrollment momentum.
• Identify and document monitoring findings, risks, and corrective actions.
• Prepare high-quality monitoring reports and follow-up communications.
• Track findings and action items through resolution and verification.
• Oversee regulatory documents and inspection readiness.
• Lead site start-up and closeout activities as needed.
• Mentor junior staff on monitoring standards and best practices.
• Monitor subject safety and escalate adverse events as required.

Skills

Site management

Monitoring visits

SDV/SDR

ICH-GCP compliance

Regulatory knowledge

Risk-based monitoring

Data quality

Documentation

Mentoring junior CRAs

Job description

The Sr. Clinical Research Associate is responsible for advanced clinical site management and monitoring across our clients 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.

• 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 escal ...