Contract Clinical Research Associate (~50%)
Job #: 10706
Location: US East of the Mississippi
Job Type: 1099
Therapeutics: Metabolic / Endocrinology
One of our partner organizations is seeking 1 or 2 Contract CRAs anywhere US East of the Mississippi to monitor Metabolic / Endocrinology studies at about 50% utilization.
- 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.
- 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 US East of the Mississippi
- Must have at least one year of experience monitoring Metabolic / Endocrinology studies
- Experience monitoring Rare / Orphan Disease or Genetic Diseases a plus
- About 50% Utilization required
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