Sponsor Clinical Research Associates – Hema/Oncology
Category: CRA
Job #: 10915
Utilization: 50%↑
Location: ET or CT Timezones in US and Canada
Job Type: 1099
Therapeutics: Hema/Oncology
We are thrilled to share an excellent opportunity with one of our Sponsors. They are seeking experienced Contract Clinical Research Associates to support impactful Phase I Hema/Oncology studies. This is a chance to work with a highly respected and stable team while enjoying flexibility and meaningful engagement. If you’re looking to bring your expertise to a Sponsor that values collaboration and excellence in clinical research, this is an exciting team to join.
Job Responsibilities:
- Act as the "Site Manager," ensuring relationships 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:
- Qualified CRAs will have at least 5 years' experience as a fully dedicated regional, home-based, field monitor, having gained that experience from a CRO or Pharma.
- Must have at least two years' experience monitoring Hema/Oncology studies.
- Strong experience in monitoring phase I studies required (preferred at least 1 year).
- Proven track record in site management required.
- While minimal travel is expected, CRAs must be able and willing to travel as required.
- Must have at least 50% utilization available.
- This position requires that you have received the COVID-19 vaccination.
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