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Medpace · 4 hours ago

Medpace PhD Virtual Info Session - February 5th

Cincinnati, OH

Full-time

Onsite

New Grad, Entry Level

Medpace is a full-service clinical contract research organization (CRO) that is hosting a virtual informational session to highlight roles for PhD/Posdoc graduates. They are seeking full-time, office-based PhD graduates to join their Clinical Trial Management, Clinical Monitoring, and Study Start Up Teams, focusing on various responsibilities within clinical trial operations.

BiotechnologyPharmaceutical

Responsibilities

Communicate and collaborate on global study activities; working closely with the project coordinator and clinical trial manager

Ensure timely delivery of recurrent tasks consistently with a high degree of accuracy

Compile and maintain project-specific status reports within the clinical trial management system

Interact with the internal project team, Sponsor, study sites, and third-party vendors

Provide oversight and quality control of our internal regulatory filing system

Provide oversight and management of study supplies

Create and maintain project timelines; and

Coordinate project meetings and produce quality minutes

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; and

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

Communicate with research sites (doctor's offices, universities, hospitals, etc.) to collect all essential documents required before the site begins to screen patients to participate in the clinical trial

Maintain and perform ongoing quality review of trial documents within the Trial Master File (TMF)

Collect, review, organize, and assemble regulatory start-up submissions (including submissions to Institutional Review Boards (IRB)

Maintain timelines for study start-up through both internal and external collaboration; and

Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges

Qualification

PhD in Life SciencesClinical Research ExperienceRegulatory KnowledgeFluency in EnglishComputer SkillsCommunication SkillsOrganizational SkillsPresentation Skills