Posted on 22 Feb 2026

Clinical Research Associate

Remote
Permanent
$70,000 - $90,000

Position Summary

The Clinical Research Associate (CRA) is responsible for supporting the execution, monitoring, and operation success of clinical studies, with a focus on high-quality trial conduct and compliant data collection. The CRA ensures studies are executed in accordance with approved protocols, applicable regulations, and internal quality standards. 

This role partners closely with investigative sites and cross-functional stakeholders (e.g. Clinical Operations, Regulatory, Quality, Medical Affairs, R&D, and other internal teams as needed) to support study timelines, site performance and the generation of credible clinical evidence. 

The ideal candidate is highly organized, detail-oriented, and comfortable building trusted relationships with site staff while maintaining strong compliance discipline and proactive issue resolution. 

Essential Duties and Responsibilities 

Study Monitoring & Site Management

  • Conduct site monitoring activities (on-site and remote), including:
    • Site qualification (as applicable)
    • Site initiation visits (SIV)
    • Interim monitoring visits (IMV)
    • Close-out visits (COV)
  • Verify subject eligibility, informed consent, and ongoing protocol compliance.
  • Perform source data verification (SDV) and ensure timely query resolution in collaboration with sites and data management.
  • Track and report on enrollment, deviations, data quality trends, and site performance metrics.
  • Serve as a primary point of contact for investigators and study coordinators; build and maintain productive, professional site relationships.
  • Identify risks to study quality or timelines and escalate appropriately with proposed mitigation actions. 

Regulatory Compliance & Documentation

  • Maintain accurate and inspection-ready essential documents; support ongoing upkeep of the Trial Master File (TMF/eTMF).
  • Ensure appropriate investigational device accountability (as applicable), including tracking, reconciliation, and documentation at study sites.
  • Support preperation, collection, and submission of IRB/EC documentation, including amendments, continuing review/annual reports, and site correspondence as needed.
  • Prepare and submit monitoring visit reports, follow-up letters, and other study-related documentation within required timelines. 

Clinical Operations Support

  • Support site feasibility and site selection activities (e.g., pre-study assessments, site capability review).
  • Collaborate with clinical operations leadership to maintain study timelines, deliverables, and operational consistency across sites.
  • Contribute to development and refinement of study tools, which may include:
    • Monitoring plan(s)
    • Site training materials
    • Study reference guides/manuals
    • Visit checklists and templates
  • Coordinate effectively with external partners (e.g., CROs, core labs, imaging providers, other vendors) to support study execution.
  • Participate in ongoing data review, signal detection, and quality initiatives; contribute to audit/inspection readiness.
  • Responsibilities may evolve based on program needs and organizational growth.

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Bachelors' degree in a scientific, healthcare, or related discipline (or equivalent experience).
  • 5+ years of clinical research experience; medical device experience strongly preferred.
  • Working knowledge of GCP, ISO 14155, and applicable FDA/ICH requirements.
  • Demonstrated experience conducting monitoring visits and reviewing clinical data for completeness, accuracy, and compliance.
  • Strong written and verbal communication skills; ability to produce clear, timely documentation.
  • Strong organizational skills with the ability to manage competing priorities independently.
  • Proficiency with clinical systems such as EDC, CTMS, and eTMF platofmrs.
  • Ability to travel up to 40%.

Preferred Qualifications 

  • Experience with cardiovascular, vascular, interventional, or similarly complex device trials.
  • Experience supporting device accountability processes and/or imaging-based endpoints.
  • Experience working with CROs and multi-site study operations across regions.
  • Familiarity with risk-based monitoring approaches and inspection-readiness best practises.
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