Contract Clinical Research Associate
One of our Partners is looking for a contract CRA anywhere in the US with at least 50% utilization available (and the ability to ramp up within a few months). Must have experience in at least one of the following therapeutics: Autoimmune Disease, Cardiovascular, Cell/Gene/Stem therapy, Hema/Oncology, Oncology, or Infectious Disease.
- 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 5 years' recent experience as a fully dedicated Regional, Home-Based, Field Monitor for a CRO or Pharma
- Can be located anywhere in the US
- Must have experience in at least one of the following therapeutics: Autoimmune Disease, Cardiovascular, Cell/Gene/Stem therapy, Hema/Oncology, Oncology, or Infectious Disease
- Experience with Endocrinology/Metabolism, Neurology/CNS/Psychiatry, or Rare and Orphan Diseases is a plus
- A Bachelor's Degree is required
- 2-dose COVID-19 Vaccination required
- At least 50% Utilization required, with the ability to ramp up within a few months