Contract Clinical Research Associate, Oncology Sponsor

Category: CRA
Job #: 10950
Utilization: 50%↑
Location: West or Southwest
Job Type: 1099
Therapeutics: Hema/Oncology and Phase I

Looking for a Sponsor that values collaboration, steady partnerships, and quality research? One of craresources' long-standing Sponsor partners needs experienced Contract Clinical Research Associates in the West or Southwest US to oversee sites on Phase I Hema/Oncology studies. You'll be hands-on with your sites, have flexibility in how you manage your work, and join a team that values long-term relationships with its CRAs. If you're ready to put your monitoring expertise to work in a setting where it's truly appreciated, this could be your next great fit.

Job Responsibilities:
  • Act as the "Site Manager" ensuring relationship with site(s) are positive, issues are resolved quickly, and communications are strong across all verticals.
  • Assist with the development of study manuals, CRFs, monitoring standards, site study tools and other study materials as required.
  • Develop and implement site recruitment, selection and initiation plan.
  • Manage and drive patient recruitment and enrollment tracking.
  • Provide training to sites on the study protocol, study conduct, CRF completion and data management expectations.
  • Ensure essential document collection for completeness per regulatory requirements.
  • Serve as a liaison with Investigators, Institutions and sites to provide support during the conduct of the clinical trial and serve as a resource for protocol and procedures.
  • Demonstrate knowledge of on-site monitoring to ensure compliance with GCPs, study protocols, and SOPs.
    Manage one or multiple studies.
  • Monitor product supplies/accountability including proper storage, dispensation, and disposal.
  • Manage study completion activities including CRF collection, query resolution, record archiving and site closeout activities.
  • Review in-house data and study tables.
  • Mentor, coach and provide guidance to clinical staff as appropriate.
  • Supervise and train other employees as appropriate.
Job Qualifications:
  • Minimum of 5 years' experience as a fully dedicated regional, home-based, field monitor, with this experience being within the past 2 years
  • At least 2 years' experience monitoring Hema/Oncology studies
  • At least 1 year of experience monitoring Phase I studies
  • Current GCP certification
  • Strong site management skills
  • Located in the West or Southwest US
  • Bachelor's degree, nursing, or similar medical background (preferred)
  • Solid Tumor Oncology or Lymphoma experience (preferred)
  • Experience monitoring multiple protocols at the same time (preferred)
  • Experience working with small to mid-sized Sponsors (preferred)
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