Job Responsibilities:
Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol;
Communicate 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;
Verify medical record and research source documentation against case report form data, ensuring good documentation practices and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;
Ensure that the investigator is enrolling only eligible subjects;
Review regulatory documents;
Account for medical devices and/or investigational products/drugs and manage inventory;
Verify and review 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 offer suggestions for improvement;
Complete monitoring reports and follow-up letters, summarizing significant findings, deviations, deficiencies, and recommended actions to secure compliance.
Qualifications:
Minimum of a bachelor's degree; health or life science related field preferred;
At least 1.5 to 5 years of experience in clinical monitoring;
Willingness to travel approximately 60-80% nationally;
Familiarity with Microsoft Office;
Strong communication and presentation skills are a plus.
No research experience is needed as Medpace provides comprehensive initial and ongoing training, unmatched by other CROs.
Through ourPACETraining Program, you will join otherProfessionalsAchievingCRAExcellence:
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.
Seniority LevelAssociate
Employment TypeFull-time
Job FunctionResearch and Other
IndustriesBiotechnology Research and Research Services#J-18808-Ljbffr