Clinical Research Associate
3 mesi fa
Job Summary The Clinical Research Associate position at Medpace offers the unique opportunity to have an exciting career in the research of drug and medical device development while making a difference in the lives of those around them.
For those with a medical and/or health/life science background who want to explore the research field and be part of a team bringing pharmaceutical and medical devices to market - this could be the right opportunity for you
Our successful Clinical Research Associates possess various backgrounds in medical and other science-related healthcare fields.
Backgrounds of individuals who have succeeded in the CRA role include: Nursing Dietetics Pharmacist Pharmaceutical/Device Sales Representative Biomedical/Chemical Engineer PhD/Post-Doc Pharm.D candidates Health and Wellness Coordinators Clinical Research Coordinators Research Assistants MEDPACE CRA TRAINING PROGRAM (PACE) No research experience is needed as Medpace provides comprehensive initial and ongoing training, unmatched by other CROs.
Through our PACE Training Program, you will join other Professionals Achieving CRA Excellence: PACE provides the platform to effectively and confidently carry out your duties, enhance your current abilities and ultimately help you become a high-functioning independent Medpace CRA.
PACE will prepare you by developing your CRA skills through interactive discussions and hands-on job-related exercises and practicums.
To supplement your in-house and field-based training you may also participate in other clinical research departmental core rotations, learning other aspects of the drug/device development and approval process.
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; 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.
Qualifications Master degree in health-related field; Willing to travel 60-80% nationally; Familiarity with Microsoft Office; CRA certification completed (as per DMC 15/11/2011); Fluent in English and Italian language; Strong communication and presentation skills a plus.
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