Highly Competitive Salary
  1. Permanent
  2. Clinical Research Associate (CRA), CRA Manager, Clinical Outsourcing
  3. United States
Austin, USA
Posting date: 18 Sep 2020

Proclinical is currently recruiting for an OCRA with a global biotechnology company located in Austin, TX. As the OCRA, you will re-train CRO CRAs and/or sites as needed.

Job Responsibilities:

  • Conduct oversight visits to assess CRO CRA and Investigational Site performance.
  • Use experience and knowledge of ICH/GCP guidelines, protocols, Investigator's Brochure, etc to identify issues and recommend solutions.
  • Escalate critical issues to the company Management team immediately, and communicate non-critical issues in a timely manner; ensure the company and CRO team are made aware of any trends that may affect multiple study sites and/or the study as a whole.
  • Write oversight visit reports, providing feedback on identified issues, actions taken and/or proposed solutions.
  • Follow-up on identified issues by conducting additional oversight visits as needed and/or working with the CRO CRA and Company/CRO management teams as needed to provide resolution.
  • Provide co-monitoring assistance to CRO CRAs.
  • Conduct pre-study visits, initiation visits, monitoring visits and/or close-out visits.
  • Assist in study document creation/revision.
  • Create training materials, conduct team trainings and/or present at Investigator Meetings.
  • Create, maintain, and/or review spreadsheets and data listings.
  • Conduct file audits.

Skills and Requirements:

  • 5+ years of experience as a Clinical Research Associate.
  • Therapeutic and/or clinical experience in chronic kidney disease and dialysis preferred.
  • Therapeutic and/or clinical experience in patient reported outcome, liver disease, and/or dermatological condition would be an advantage.
  • Ability to work across multiple trials and multiple therapeutic indication.
  • Detail-oriented with strong communication skills (oral and written) and ability to prepare accurate monitoring visit report quickly.
  • Ability to be flexible and a team player is a must.

If you are having difficulty in applying or if you have any questions, please contact Nicole Aganon at (+1) 347-293-1161 or n.aganon@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.