Clinical Research Associate

BioPhase

San Francisco (CA)

On-site

USD 61,992 - 75,768

Full time

14 days+

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Benefits offered by this job

Competitive hourly contract rate

Possibility of extension

Supportive work environment

Work-life balance flexibility

Job summary

A biotech research firm in San Francisco is seeking an experienced Clinical Research Associate on a contract basis for a minimum of 6 months. This role emphasizes laboratory oversight and regulatory compliance in IVD studies, managing monitoring activities, and collaborating with sponsors. Ideal candidates will have 3 to 5 years of CRA experience and a strong understanding of 21 CFR regulations. This position offers a competitive hourly rate with the potential for extension or transition to longer-term employment.

Qualifications

3–5+ years of experience as a CRA in IVD trials.
Solid understanding of 21 CFR Part 812.
Hands-on experience in lab-based clinical trials.

Responsibilities

Conduct comprehensive site monitoring across all trial phases.
Perform monitoring of laboratory activities.
Partner with external sponsors to align project milestones.
Oversee lab‑related operations and resolve issues.
Prepare and review monitoring documentation and reports.

Skills

Site monitoring

Laboratory oversight

Collaboration with sponsors

Regulatory compliance

Problem-solving

Organizational skills

Communication skills

Education

Bachelor’s degree in life sciences

Tools

CTMS/EDC systems

Job description

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

Clinical Research Associate

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