Contract Clinical Research Associate, Solid Tumor Oncology Sponsor

Category: CRA
Job #: 10954
Utilization: 50%↑
Location: Middle of the US preferred (TN to ID)
Job Type: 1099
Therapeutics: Solid Tumor Oncology and Phase I

We’re actively seeking an experienced, contract Clinical Research Associate (CRA) with Solid Tumor Oncology monitoring experience to support a long-standing sponsor partner of craresources. This is a mostly remote role with some travel, offering at least 50% utilization on a 1-year renewable contract. Candidates located in the middle of the US (anywhere from TN to ID) are preferred. It’s a great opportunity for hands-on site management with a sponsor that values long-term relationships, and the team is looking to fill it by early November. If this is you, please apply below!

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:
  • At least 5 years of recent experience as a fully dedicated regional/home-based field monitor for a CRO or pharma, with that role held within the last 2 years
  • At least 2 years of Solid Tumor Oncology monitoring experience (ideally Ovarian, Lung, or Anal Cancer)
  • At least 1 year of Phase I monitoring experience, in any therapeutic area
  • Bachelor’s degree, or a background as a practicing nurse (or similar medical background) with equivalent experience
  • Strong site management skills
  • COVID-19 vaccinated
  • Located in the middle of the US preferred (anywhere from TN to ID), though not required
  • Mostly remote, but able to travel as needed
  • At least 50% utilization availability
  • Experience with Phase I/II Oncology, Blood Tumor (Hema/Oncology), nursing, small to mid-sized sponsors, or studies with multiple amendments a plus
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