Senior Clinical Research Associate

Sr. Clinical Research Associate

Status : Contract - 6 months rolling

Comp : DOE $55-$65/hr DOE

Overview

We are seeking an experienced Sr. Clinical Research Associate (Sr. CRA) to join on a contract basis ( 6 months rolling). This role is focused on supporting in vitro diagnostic (IVD) studies with a strong emphasis on laboratory oversight and regulatory compliance. The CRA will manage monitoring activities across all trial phases and collaborate closely with sponsor partners to ensure high-quality execution. Candidates who excel in this position may be considered for longer-term opportunities.

Key Responsibilities

• Conduct comprehensive site monitoring (start-up, initiation, routine visits, and close-out) in line with study protocols, GCP, ICH, and applicable regulations.
• Perform monitoring of laboratory-based activities, including on-site visits, data verification, and quality assurance reviews.
• Partner with external sponsors to align project milestones, timelines, and deliverables.
• Support investigational device exemption (IDE) processes and companion diagnostic (CDx) activities in compliance with 21 CFR Part 812 and relevant EU MDR requirements.
• Oversee lab-related operations such as sample handling, processing, and reporting; resolve issues as they arise.
• Prepare and review monitoring documentation, reports, and study-related submissions.
• Assist in study planning, project documentation, and management of trial communications.
• Contribute to audits, inspections, and risk assessments to ensure regulatory readiness.
• Track study progress against timelines and provide regular status updates to stakeholders.
• Safeguard ethical conduct of research, including informed consent and subject protection.

Required Qualifications

• Bachelor’s degree in life sciences (advanced degree preferred).
• 5+ years of experience as a CRA, with a background in IVD trials and laboratory monitoring.
• Solid understanding of 21 CFR Part 812 and IDE-related processes.
• Familiarity with companion diagnostics and EU MDR Annex XIV.
• Strong collaboration skills with sponsors and cross-functional teams.
• Hands-on experience monitoring lab-based clinical trials.
• Excellent organizational, communication, and problem-solving skills.
• Proficiency with CTMS/EDC systems and standard office applications.

Preferred Qualifications

• Experience with next-generation sequencing (NGS) technologies.
• Prior work in diagnostics, genomics, or related fields.
• Knowledge of ISO 13485 and other IVD regulatory frameworks.
• Background in oncology or precision medicine is a plus.

What We Offer

• Competitive hourly contract rate.
• Possibility of extension or transition into a longer-term role.
• Exposure to advanced laboratory settings and innovative diagnostic research.
• Collaborative and supportive work environment.
• Flexibility to support work-life balance during the contract period.