Contract Clinical Research Associate (100%)
Job #: 10699
Location: Anywhere US
Job Type: 1099
Therapeutics: Hema/Oncology or Oncology
One of our partners needs several contract CRAs to monitor Oncology and Hema-Oncology Studies with at least 75% utilization. This partner values long term relationships with their CRAs and offers enormous career growth opportunities.
- Act as the "Site Manager" ensuring relationship with site(s) are positive, issues are resolved quickly, and communications are strong across all verticals.
- Monitor patient enrollment to ensure recruitment targets and project timelines are met at the site and/or country level
- Act as the main line of communication between the Sponsor and the site
- Be a point of contact / liaison for in-house support services and vendors
- Responsible for reviewing the status and contents of essential documents at the site level including reconciliation of the TMF
- 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.
- Can be located anywhere in the US close to a major airport
- At least 75% Utilization required
- Must have at least one year monitoring experience working in either Hema/Oncology or Oncology studies
- GI, ID, MS, or Rare Disease monitoring experience is a plus
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