Clinical Operations Position Profile

Responsibilities

  • Operational responsibility for the execution of clinical studies
  • Develops and executes clinical trial operational strategies that are in compliance with Good Clinical Practice (GCP)
  • Manages all aspects of relationships with Clinical Research Organizations (CROs)
  • Helps develop site qualification forms for site selection. Participates in site selection decisions.
  • Negotiates contracts and budgets with vendors and clinical sites
  • Reviews clinical protocols for operational feasibility
  • Contributes to and reviews study conduct documents such as pharmacy manuals, pharmacokinetics manuals and sample collection manuals
  • Works with CRO to develop case report forms (CRFs) and database build
  • Develops logistical strategies for the collection and shipment of PK and biomarker samples from clinical sites to vendors for analysis
  • Develops informed consent forms (ICFs)
  • Develops vendor oversight plans (including auditing of CRO and other vendors)
  • Develops and utilizes appropriate metrics to assess site and CRO performance, compliance and costs
  • Establishes performance targets for the CRO. Holds CRO accountable for meeting performance targets
  • Drafting and/or reviewing clinical department SOPs
  • Develops vendor and site corrective action plans as needed
  • Ensures audit readiness of company
  • Data review and data cleaning
  • Review of clinical research associates (CRAs) site monitoring reports

Minimum Qualifications

  • BA/BS degree preferably in nursing, pharmacy, or relevant field (biology, chemistry). Advance degree preferred.
  • 5+ years clinical oncology department experience in clinical operations or clinical science
  • Working knowledge of phase 1 and phase 2 oncology clinical study design
  • Experience working in cross-functional teams

General Skill Required

  • Communication, problem solving, leadership, etc…