Partial Contract Clinical Research Associates – Mostly Remote

Category: CRA
Job #: 10775
Utilization: 25%↑
Location: Eastern, SW, or Western US
Job Type: 1099
Therapeutics: No Specific TA Required

One of our partners has predominately Remote partial contract CRA positions available for those in both the Northeast (or surrounding states), Southwest, and Western US regions at 25% utilization (with the option to ramp up in Q1 2023). No specific TA required, but Pain Management or Diabetic Neuropathy is a plus. Experience with Study Startup / Site Activation and RBM (Risk Based Monitoring) is also a plus.

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 of 3 years' recent experience as a fully dedicated, Regional, Home-Based Field monitor for a CRO or Pharma
  • Predominately Remote
  • Must have at least 25% utilization available
  • Experience monitoring Pain Management and Diabetic Neuropathy is a plus
  • Experience with Study Startup / Site Activation and RBM (Risk Based Monitoring) is a plus
  • Experience with eSource is a plus
  • Must have COVID-19 and Flu Vaccinations

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