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Clinical Project Assistant

Parexel International Corporation

Baltimore, Maryland, United States of America

Parexel is seeking a Clinical Project Assistant to provide project support to the Project Management department. This role sits in the Baltimore, MD EPCU and requires the ability to anticipate the needs of their team members and prioritize their workload and schedule to meet those needs. The Project Management Assistant role requires the ability to maintain confidentiality and to work independently with minimal supervision in a fast-paced environment.

This position allows employees to work remotely 75% of the time. The other 25% of the time will be onsite. Applicants must be local to the Baltimore, MD area.

Your Activities:

  • Coordinating with Project Manager or Clinical Lead to complete IRB/EC submissions and maintain IRB correspondence according to IRB guidelines and regulations
  • Serving as primary contact and liaison for IRB/EC and informing team members of any new information or modifications which may affect their responsibilities.
  • Reporting to line managers any anticipated needs or performance issues
  • Supporting the Project Manager (PM) in the organization and follow-up of meetings (i.e. technical meetings, internal meetings)
  • Supporting communications among team members with timely and accurate distribution of materials and by maintaining Project Management files and meeting minutes of key meetings as required
  • Assisting in preparation and QC of documents as requested by PM
  • Preparing project timelines and team contact lists
  • Managing and coordinating the client survey and clinical trial insurance processes
  • Serving as backup point of contact for PM or Clinical Lead communications
  • Preparing and maintaining regulatory documents including but not limited to the FDA Form 1572, financial disclosures and protocol review forms for all protocols
  • Maintaining up to date laboratory documents such as CAP, CLIA, and lab director CVs and request updated certificates as required
  • Composing professional business correspondence for the PM team, clients and outside vendors
  • Preparing and filing invoices
  • Scheduling and preparing for monitoring and sponsor visits
  • Booking travel and prepare expense reports
  • Monitoring the front desk during am hours and as required for client visits/visitors
  • Supporting and coordinate contract review/signature process with the Parexel contract team
  • Other activities as needed
Your Skills:
  • Comprehensive knowledge of Microsoft Windows Operating System and the MS Office Suite including Word, Excel, Outlook, and PowerPoint
  • Highly organized with the ability to manage multiple conflicting deadlines and competing priorities
  • Ability to work in a fast-paced environment with minimal supervision
  • Ability to liaise with senior management within Parexel
  • Excellent communication and proficiency in the English language (oral and written)
Your Profile:
  • At least 1-2 years in a similar administrative position or work experience.
  • Clinical trial experience required
  • Experience in dealing with confidential materials
  • High school diploma or equivalent required
  • College degree preferred
  • Experience with Veeva Vault highly preferred
  • Reside in or live within commuting distance to Baltimore, MD
This role may be subject to government and/or customer requirements regarding vaccination against COVID-19 that are more stringent than Parexel policy.  Accordingly, successful applicants may need to be either vaccinated against COVID-19 or have an approved religious or medical exemption. Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

Job posted: 2023-05-27

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