Clinical Research Associate (Northeast US)
Job #: 10583
Location: Northeast US
Job Type: 1099
Rate / Salary Range: Competitive Fixed Unit Rates
One of our Partners who specializes in rare disease is looking for a CRA to monitor sites in the Northeast US. This is a 50% contract with Competitive Fixed Unit Rates and doesn't require any specific therapeutic experience.
- 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.
- 4+ years experience as a fully dedicated, regional, home based, field monitor for a CRO or Pharma
- 50% available utilization
- Rare and/or Orphan disease monitoring experience is a plus
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