Responsibilities
Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol; Communication with the medical site staff including coordinators, clinical research physicians and their site staff; Verifying 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; 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; Assessing 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
Bachelor's degree in a health or science related field and with at least 1.5 to 5 years of experience in clinical monitoring; Knowledgeable about Clinical Monitoring practices and procedures to represent the function in internal and external (e.g., business development) meetings.
PACE – MEDPACE CRA TRAINING PROGRAM
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 P rofessionals A chieving C RA E xcellence:
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.
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