Sponsor Contract Clinical Research Associates

Category: CRA
Job #: 10907
Utilization: 10%
Location: New York, NY / Chicago IL / Stanford CA
Job Type: 1099
Therapeutics: Oncology

Are you a skilled CRA looking to make a meaningful impact? One of our terrific, smaller-sized sponsors is launching a groundbreaking Glioblastoma study and is seeking CRAs to support the project from prequalification visits all the way through closeout. This is a fantastic opportunity to be part of a collaborative team that values flexibility, accountability, and strong communication. If you are committed, adaptable, and ready to contribute your expertise to an important study, we would love to hear from you!

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:
  • A minimum of 5 years’ experience as a fully dedicated regional, home-based, field monitor for a CRO or pharma (Hourly rate commensurate with experience).
  • Must have at least 1 year of experience monitoring oncology or hema/oncology studies.
  • This project is a phase I dose escalation study. At least one year's previous experience monitoring Phase I with strength monitoring dose escalation trials is required.
  • Previous experience independently conducting prequalification visits is required.
  • COVID vaccination is required due to site requirements (all visits are on-site).
  • Utilization is expected to be between 10-20% for the next year to 18 months.
  • Must be located in the New York NY, Chicaco IL, or Stanford CA areas within one hour commute to a major airport.
  • The hourly rate is competitive; reach out to speak about details!
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