Medpace PhD Virtual Info Session - February 11th

Medpace, Inc.•Cincinnati, OH

4h•Onsite

About The Position

Medpace is hosting a virtual informational session to highlight various full-time, office-based roles for PhD/Postdoc graduates within its rapidly growing clinical operations. The session will provide an overview of Medpace, its robust training programs, and career growth opportunities in Clinical Trial Management, Clinical Monitoring, and Study Start Up Teams. The virtual event is scheduled for Wednesday, February 11th, from 12:00-1:00 pm EST, with the link provided to selected applicants. Medpace is a full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Its mission is to accelerate the global development of safe and effective medical therapeutics through a scientific and disciplined approach, leveraging local regulatory and therapeutic expertise across major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral, and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs over 5,000 people across 40+ countries.

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

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
Validate entry database designs
Report metrics and data trends on projects
Identify data conflicts and issues on projects
Work with personnel from global research sites to resolve data conflicts
Reconcile data from multiple sources
Create and update study documentation on projects
Participate as part of a team on various projects