Travel-Ready CRA – Cardiology Trials

Meditrial; New York (NY); Vor Ort; USD 90.000 - 150.000; Vollzeit

Zusammenfassung

Meditrial USA Inc. is seeking a certified Clinical Research Associate (CRA) with extensive experience in medical device clinical trials to join our dynamic team in New York. The role focuses on monitoring Phase I–IV studies and maintaining GCP and protocol compliance across sites.

You will conduct site evaluations, initiation, interim and close-out visits, review CRFs, and collaborate closely with Clinical Project Managers and CTAs. Travel for monitoring activities is required.

Qualifikationen

• 6+ years of experience in clinical trial monitoring for CROs and Sponsors, with a strong focus on medical device trials.
• Expertise in cardiology trials and experience across other therapeutic areas.
• CRA Certification with a track record of successful monitoring visits.
• Fluency in English (a second language is a plus).
• Willingness to travel for site visits and monitoring activities.

Aufgaben

• Conduct on-site and remote monitoring visits from SIV to COV, ensuring study sites adhere to protocols and regulatory requirements.
• Train investigators and site personnel on study protocols and best practices.
• Review Case Report Forms (CRFs) and verify entries against source documentation.
• Document site visits, findings, and follow-ups in detailed reports.
• Facilitate communication among investigative sites, sponsors, and internal teams.
• Identify and assess potential investigators in collaboration with sponsors.
• Ensure compliance with FDA, ICH-GCP, and local regulatory guidelines.
• Assist in study submissions and preparation of regulatory documents.
• Support project teams with study communications and trial management activities.

Kenntnisse

Clinical trial monitoring

eCRF proficiency

CTMS proficiency

FDA/ICH-GCP knowledge

Travel readiness

Ausbildung

Higher degree in natural sciences

CRA Certification

Tools

eCRF

CTMS

Jobbeschreibung

Meditrial USA Inc. is seeking a certified Clinical Research Associate (CRA) with extensive experience in medical device clinical trials to join our dynamic team in New York. The role focuses on monitoring Phase I–IV studies and maintaining GCP and protocol compliance across sites.

You will conduct site evaluations, initiation, interim and close-out visits, review CRFs, and collaborate closely with Clinical Project Managers and CTAs. Travel for monitoring activities is required.