Clinical Research Associate II (CRA II)

Mykelly; Henderson (NV); Remote; USD 166.194.000 - 183.386.000; Vollzeit

Zusammenfassung

Kelly Science & Clinical is seeking a Clinical Research Associate II for a six-month, full-time contract. This remote, home-based role supports regional studies across the Western U.S. You will monitor clinical sites and ensure studies follow ICH-GCP and approved protocols.

The position requires a life sciences degree and 3+ years of on-site CRA monitoring with experience in oncology or related areas. Travel up to 80% is expected, and CTMS/EDC tools familiarity is required to maintain study

Qualifikationen

• 3+ years of on-site CRA monitoring experience as the primary monitor.
• Experience monitoring complex drug studies in oncology or related areas.
• Strong knowledge of ICH-GCP, regulations, and study procedures.

Aufgaben

• Conduct remote and on-site monitoring visits using risk-based monitoring practices.
• Review source documents, verify data and CRFs for accuracy.
• Assess investigational product inventory and related records.
• Ensure site activities comply with protocols, ICH-GCP, applicable regulations, and project procedures.
• Identify site issues, document findings in monitoring reports and follow-up letters, elevate deficiencies, and track issues through resolution.
• Maintain regular communication with investigative sites, client teams, and project colleagues.
• Support site selection, initiation, ongoing management, and close-out activities.
• Maintain study tracking systems, such as CTMS, and provide study status updates to the Clinical Team Manager.
• Support audit readiness and respond to audit, inspection, and quality requirements.
• Complete required administrative tasks, including timesheets and expense reports.
• Mentor newer team members and support project tools, training, and process‑improvement efforts as needed.

Kenntnisse

3+ years on-site CRA monitoring

Risk-based monitoring

ICH-GCP knowledge

EDC experience

CTMS familiarity

Travel up to 80% (regionally)

Valid driver's license

Ausbildung

Bachelor's degree in life sciences

Tools

CTMS

EDC

Jobbeschreibung

Clinical Research Associate II (CRA II)

Kelly® Science & Clinical is seeking a Clinical Research Associate II for a six-month, full-time contract position with a large clinical research organization (possibility of extension/conversion). This remote, home-based position supports regional clinical studies across the Western U.S. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Pay Rate:

$58–$64/hour

Overview

Our client is a large clinical research organization supporting clinical trials across a range of therapeutic areas. In this role, you’ll independently monitor clinical trial sites and help ensure studies are conducted in accordance with approved protocols, ICH-GCP guidelines, applicable regulations, and standard operating procedures.

Schedule

Full-time, home-based contract, regional travel up to 80%

Responsibilities

• Conduct remote and on-site monitoring visits using risk-based monitoring practices.
• Review source documents, verify study data, and review case report forms for accuracy and completeness.
• Assess investigational product inventory and related records.
• Confirm that site activities and essential documents comply with study protocols, ICH-GCP guidelines, applicable regulations, and project procedures.
• Identify site issues, document findings in monitoring reports and follow-up letters, elevate deficiencies, and track issues through resolution.
• Maintain regular communication with investigative sites, client teams, and project colleagues.
• Support site selection, initiation, ongoing management, and close‑out activities.
• Maintain study tracking systems, such as CTMS, and provide study status updates to the Clinical Team Manager.
• Support audit readiness and respond to audit, inspection, and quality requirements.
• Complete required administrative tasks, including timesheets and expense reports.
• Mentor newer team members and support project tools, training, and process‑improvement efforts as needed.

Qualifications

• Bachelor’s degree in a life science‑related field.
• 3+ years of on‑site CRA monitoring experience as the primary monitor.
• Experience monitoring complex drug studies in therapeutic areas such as oncology, CAR‑T, rare disease, neurology, or infectious disease.
• Strong understanding and practical application of ICH‑GCP, applicable regulations, and study procedures.
• Experience with risk-based monitoring, source document review and verification, EDC, and CTMS platforms.
• Valid driver’s license and ability to travel regionally up to 80% as needed.
• Current residence in California, Nevada, Colorado, Utah, or Arizona.