Description
The Senior Clinical Research Associate (Sr. CRA) is responsible for:- Performing clinical study or clinical site feasibility
- Contributing to the preparation of clinical protocols and amendments
- Will assist in the activities associated with site start-up and management
- Supports the administration of study budgets
- Coordinates the preparation and conduct Investigator Meetings
- Monitors progress of studies, identifying delays and initiating corrective actions
- Tracking study related trends
- Supporting CRO and vendor relationships
- Monitoring clinical sites for adherence to protocol, GCP and company SOPs
- Ensuring quality of data generated from clinical sites and assist in resolving patient eligibility and protocol deviation issues
- Ensuring adverse events are reported properly and following up in a timely manner
- Assisting with operational activities associated with clinical studies; This may include communicating with sites, various CROs and vendors involved in the studies
- Reviewing regulatory documents, tracking in database and filing in the Trial Master Files
- Contributing to the administrative details of the following materials for clinical trial conduct: informed consent forms, study instructions, case report forms (CRFs) clinical trial binders, subject status tracking etc.
- Assisting in the tracking and administration of study budgets
Education, Skills and Experience:
- BA or BS in the sciences field with 3-5 years experience working in the industry as a CRA is required (at least one year of monitoring experience)
- Excellent written and verbal communication skills
- Works independently and collaboratively to provide high quality work
- Team-oriented with ability to work in fast paced environment
To find out more about Real please visit www.realstaffing.com