Clinical Research Associate

This range is provided by BioPhase. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$45.00/hr - $55.00/hr

Status: Contract - 6 months

Comp: DOE $45-$55/hr DOE

Overview

We are seeking an experienced Clinical Research Associate (CRA) to join on a contract basis (minimum 6 months). 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).
• 3–5+ 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.

Seniority level

Associate

Employment type

Contract

Job function

Science and Research

Industries

Biotechnology Research and Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at BioPhase by 2x