Freelance Full Time Temporary

Contract Senior CRA

Urgent
Posted 2 months ago
AL Solutions - Halkin
Apply Now

Job Description

Contract Senior CRA

AL Solutions are working with a small + expanding Rare Disease Biotech company based in Baltimore, USA. As part of their growth, we are looking to find an experienced Senior CRA to work on a 6 month contract (likely to extend OR turn perm).

We’re looking for someone based fairly close to Baltimore or commutable near the DC Metro area.

Right now, everybody is working remotely (due to COVID) but they anticipate part-office based working afterwards. Therefore, commutable distance is preferred.

Responsibilities

  • Assist with Management of external vendors (CROs, labs etc)
  • Participate in protocol review
  • Responsible for preparation of materials for Investigator meetings
  • Focus on quality by design in clinical trials
  • Manage TMF for assigned studies

Site Monitoring/Management responsibilities

  • Collectino and review of site regulatory documents
  • Source data verification of all data entry
  • Provide site management and monitoring expertise to assigned studies
  • Review essential documents
  • Work closely with clinical operations to ensure timely resolution of site management issues
  • Proactively identify and resolve any study issues
  • Contribute to the selection of, and negotiation with, clinical study sites

Requirements

  • 4+ years’ on-site monitoring experience
  • 5+ years’ experience working for sponsor is preferred, some CRO also advantageous
  • Prior experience with EDC systems

To find out more, please submit your application.