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Sr CRA - East Coast

Post Date: 05/23/2017 Job ID: 1393 Job Category: Clinical: Clinical Operations and Development

Growing International CRO is building a US monitoring team. Oncology or complex therapeutic area monitoring experience is required.  Monitoring regions are West Coast, East Coast and Texas near major airports.

Job Responsibilities:
  • Administration and full investigator site responsibility for clinical studies
  • May assume line management responsibilities for CRAs and assist PM as needed
  • Ensures clinical trials are monitored such that subjects' rights, safety and well-being are protected and that the clinical trial data are reliable.
  • Contributes to Case Report Form (CRF) design and clinical trial document development as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.);
  • Negotiates investigator budgets and assists with the execution of site contracts with support from the legal department;
  • Involved in recruitment of potential Investigators, preparation of Independent Ethics Committee/ Independent Regulatory Board (IEC/IRB) submissions, notifications to regulatory authorities
  • Performs pre study visits
  • Performs initiation visits
  • Performs monitoring visits
  • Understands and updates Clinical Trial Management System (CTMS) in a timely manner
  • Monitors and updates data in an Electronic Data Capture (EDC) system
  • Demonstrates a broad understanding of the SAE reporting process to regulatory authorities
  • May write SAE narratives to support pharmacovigilance activities
  • Prepares accurate and timely visit reports from all types of visits
  • Assists in business development

Qualifications/ Requirements:
  • Graduate, postgraduate, 4-year college degree or equivalent, ideally in a scientific or healthcare discipline.
  • Three (3) years or more as Clinical Research Associate (CRA) either in Clinical Research Organization (CRO) or pharmaceutical industry.

Kathleen Hepburn, SPHR
Senior Recruiter

Kathleen has been providing Human Resources and Recruiting solutions to a wide range of organizations for over 20 years. Her areas of expertise include talent sourcing and acquisition, HR planning, employee relations, and performance management. She is credited with developing strategic partnerships to quickly identify and recruit talent; leading corporate initiatives to grow revenues and reduce expenditures; and creating effective programs to train, retain and reward employees.
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