In-House CRA II / Senior In-House CRA

Functional Services United States


Position at Premier Research

You’ll be accountable for:

  • Managing Study Master Files
  • Collecting contracts, requesting/collecting relevant (i.e. Regulatory Docs, FDF, CV/ML) investigator/site documentation, reviewing and approving documents in applicable database
  • Processing core study documents (upload, assign attributes, file, review and approval in eTMF)
  • Ensuring successful study start-up (e.g site initiation visit preparation, product shipment, start of patient enrolment) and study conduct throughout the study
  • Ensuring the validity, correctness, and completeness of clinical data reviewed and collected at assigned sites as dictated by trial protocol, ICH-GCP/ISO 141155, and customer requirements, as needed

You’ll be responsible for:

  • Monitoring data remotely, as needed, with a focus on data integrity and patient safety, in accordance with specific country regulations
  • Working with the line manager and CM to ensure that visit metrics are maintained as required.
  • Gauging the quality of clinical deliverables and addressing quality issues with team members
  • Managing query resolution with study sites and Premier Research data management operations.
  • Maintaining the project tracking system of subjects and site information
  • Maintaining contact with investigator sites via telephone calls
  • Ensuring adherence to study timelines and budgets.
  • Identifying and escalating potential risks and identifying retraining opportunities for site study teams.
  • Perform budget negotiations and/or interact with internal legal team , as needed

You'll need this to be considered:

  • Bachelor’s Degree required
  • 5+ years of relevant clinical research experience
  • Background in human clinical study experience required
  • Experience working with CTMS and eTMF systems
  • Experience with Informed Consent review
  • Experience working with Institutional Review Board(s)
  • Must have experience with inspection readiness and NDA submission
  • Must have oncology experience