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Medpace · 1 day ago

Clinical Research Coordinator to Home-Based CRA (Clinical Research Associate)

San Francisco, CA

Full-time

Hybrid

Entry, Mid Level

$70K/yr - $140K/yr

1+ years exp

Medpace is a full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services. They are seeking Clinical Research Coordinators to transition into Clinical Research Associates, offering training and the opportunity to work from home.

BiotechnologyPharmaceutical

Responsibilities

Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol

Communication with the medical site staff including coordinators, clinical research physicians, and their site staff

Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff

Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements

On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward

Verification that the investigator is enrolling only eligible subjects

Regulatory document review

Medical device and/or investigational product/drug accountability and inventory

Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol

Assess the clinical research site’s patient recruitment and retention success and offering suggestions for improvement

Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance

Qualification

Clinical Research Coordinator experienceBachelor’s degree in health/scienceMicrosoft Office proficiencyCommunication skillsPresentation skillsDetail-orientedTime management