Positions Currently Open

CLINICAL RESEARCH ASSOCIATE II

LOCATION: NATIONWIDE (home-based, near major airport)

ACCOUNTABILITY
Monitor clinical trial site activity to ensure that data collected is accurate, complete, and GCP compliant. Requires approximately 70% travel.

KEY RESPONSIBILITIES:

  • Conduct monitoring at clinical trial site to ensure compliance with GCPs, study protocol, and SOPs including source document review and/or case report form data for integrity and consistency.
  • Generate and resolve queries.
  • Serve as contact with sites to provide support during the conduct of the clinical trial and serve as a resource for the clinical sites for protocol and procedural questions.
  • Track and account for the review of all CRFs for studies assigned.
  • Provide training to sites on study conduct, CRF completion and data management expectations.
  • Prepare expense reports, visit reports and schedule subsequent visits in accordance with client expectations and within the confines of the study budget.
  • Monitor available drug supply at the clinical sites.
  • Assist in the identification of potential investigators and criteria to qualify the site.
  • Assist in the preparation of instruction manuals, monitor plans and newsletters.
  • Develop and adapt monitoring tools.
  • Participate in start-up study activities.
  • Review in-house data.

QUALIFICATIONS

  • Bachelor’s degree, biological sciences or nursing preferred
  • 3 years current monitoring experience; 2 years oncology clinical trials experience
  • Strong organizational skills and attention to detail
  • Strong verbal and written communication
  • Demonstrated knowledge of GCPs, clinical protocols, case reports forms
  • Demonstrated ability to work independently as well as part of a team
  • Ability to travel up to 70%