Senior Clinical Research Associate - Remote

Posted Yesterday

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Contract

USA

Clinical Research

Data Verification

Site Monitoring

Regulatory Compliance

Organizational Skills

Overview

The Senior Clinical Research Associate position at Karius involves ensuring the accuracy and traceability of data collected for clinical studies, supporting site management, and assisting in clinical study materials development.

In Short

Support Clinical Trial Manager with site management activities.
Conduct remote and onsite monitoring visits to ensure protocol adherence.
Perform Source Data Verification (SDV) and manage case report forms.
Track regulatory document submissions and approvals.
Provide training to site staff on study procedures.
Oversee investigational product tracking and inventory management.
Implement patient recruitment strategies and monitor enrollment.
Document monitoring activities and site correspondence.
Assist in audit readiness and regulatory inspections.
Participate in the development of study documents.

Requirements

Bachelor’s degree in Life Sciences, Nursing, or related field.
4-6 years of clinical research experience.
Experience in site monitoring and complex studies.
Understanding of ICH-GCP and regulatory requirements.
Proficiency with EDC systems and CTMS.
Excellent communication and organizational skills.
Ability to work independently and collaboratively.
Strong attention to detail.

Benefits

Opportunity to impact patient care through innovative research.
Work in a dynamic and inclusive environment.
Collaborate with a team of scientists and professionals.
Engage in continuous process improvement initiatives.
Potential for professional growth and development.

Karius

Karius is a venture-backed life science startup dedicated to revolutionizing the detection and understanding of pathogens and microbes within the human body. By leveraging advanced genomic sequencing and machine learning technologies, Karius provides clinicians with a comprehensive testing platform capable of identifying over a thousand pathogens directly from blood samples. This innovative approach not only aids in the rapid diagnosis of infectious diseases but also supports industry partners in biomarker discovery and clinical trials, ultimately aiming to reduce patient suffering on a global scale. The Karius team, composed of scientists, statisticians, engineers, and physicians, is united by a mission to improve patient care through groundbreaking advancements in microbial analysis.

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