Medpace PhD Virtual Info Session - February 5th

Medpace, Inc.•Cincinnati, OH

6h•Onsite

About The Position

Medpace will be hosting a virtual informational session to highlight a variety of roles that hire PhD/Posdoc graduates. Our clinical operations activities are growing rapidly, and we are currently seeking full-time, office-based PhD graduates to join our Clinical Trial Management, Clinical Monitoring, and Study Start Up Teams. The virtual event will overview Medpace, our robust training programs, and opportunities for career growth within each of these career paths. Date: Thursday, February 5th Time: 12:00-1:00 pm EST Location: Virtual - link provided to applicants selected to attend.

Requirements

PhD in Life Sciences
Fluency in English with solid presentation skills
Ability to work in a fast-paced dynamic industry within an international team
Excellent computer (word-processing, databases, Excel, Windows), organizational, and communication skills
Willingness to relocate to our Cincinnati, OH or Dallas, TX office.

Nice To Haves

Prior experience within the CRO or pharmaceutical industry not required but will be advantageous

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