Sponsor Perm Clinical Research Associates

Category: CRA
Job #: 10855
Utilization: 100%
Location: Northern US
Job Type: Perm or Contract to Perm
Therapeutics: Oncology and/or Hema/Onc

We have exciting opportunities with an awesome Sponsor who needs Perm CRAs (or contractors open to Perm conversion) in the Northern US with travel flexibility and Oncology and Early Phase experience (T Cell and/or Gene/Cell Therapy is a plus). Must have a minimum 3 years' recent experience as a fully dedicated Regional, Home-Based, Field Monitor for a CRO or Pharma.

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:
  • Must have a minimum 3 years' recent experience as a fully dedicated Regional, Home-Based, Field Monitor for a CRO or Pharma.
  • Must be located in the Northern US (close to a major airport) and have travel flexibility
  • At least 1 year of experience monitoring Oncology and/or Hema/Oncology is required
  • Must have Early Phase through Phase 3 experience
  • T Cell and/or Gene/Cell Therapy experience is a plus
  • Experience with MediData RAVE and measurement/grading tools like RECIST is a plus

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