Clinical Research Associate II

This is a fully remote position, open to applicants in United States.

📋 Description

• Conduct independent monitoring visits both on-site and remotely, including SQVs, SIVs, IMVs, and COVs.

• Perform source data verification and source data review.

• Foster relationships with assigned investigative sites, overseeing enrollment, addressing queries, ensuring protocol compliance, and managing study activities.

• Recognize and document risks at the site level, including protocol deviations, compliance issues, and data inconsistencies.

• Create monitoring visit reports and follow-up communications.

• Monitor findings, site action items, and unresolved issues until they are resolved.

• Assist in developing corrective and preventive action plans in response to protocol deviations or compliance issues.

• Ensure the maintenance of essential regulatory and study documents, including ISFs and TMF completeness.

• Carry out site readiness assessments and provide training to site staff on protocols, procedures, systems, and specimen handling.

• Aid in study start-up, site activation, closeout, reconciliation, and necessary documentation.

• Review AE and SAE documentation, escalating discrepancies or safety concerns as needed.

• Monitor and reconcile specimen kit inventory, handling documentation, and chain-of-custody records.

• Maintain accurate information across EDC, CTMS, and eTMF systems.

• Collaborate with Clinical Trial Managers and cross-functional study teams.

• Act as the primary day-to-day contact for assigned sites, providing guidance to less experienced CRAs or CTAs.

⛳️ Requirements

• Bachelor's degree in life sciences or a health-related field, or an equivalent combination of education and experience.

• Three to five years of experience in clinical research monitoring, with a focus on independent site management responsibilities.

• Familiarity with ICH-GCP E6(R2) guidelines and relevant clinical research regulations.

• Capability to independently plan, execute, and report on both on-site and remote monitoring visits.

• Proficiency in using EDC, CTMS, and eTMF systems.

• Excellent written and verbal communication skills.

• Ability to identify, escalate, and assist in resolving site-level risks and compliance issues.

• Strong organizational skills with the capacity to manage multiple sites and prioritize competing tasks.

• A valid driver's license is required.

• Preferred: Experience in monitoring diagnostic, IVD, or molecular biology clinical studies.

• Preferred: ACRP (CCRA) or SoCRA (CCRP) certification, or ongoing progress towards certification.

• Preferred: Experience in mentoring or supporting the onboarding of junior CRAs.

🏝️ Benefits

• Equal employment opportunities.

• Disability accommodations for qualified individuals.