Job Number: 415812
Clinical Research Associate - Southeast
Regional CRA Needed in the SouthEast
SITE LOCATIONS: Florida, North Carolina, South Carolina - Candidate must live in this area, not just willing to travel to it.
- Delivery of high quality data according to agreed timelines and budget, ensuring adherence to international and local regulations and company SOP standards
- Demonstrate exceptional customer focus as evidenced by positive feedback from colleagues and external customers (Investigators)
- Participate in the site nomination process; perform evaluation of site capability to deliver the contractually agreed to number of patients and high quality data then make recommendation for inclusion in the clinical trial. Assume ambassadorial role to facilitate communication between sites and line functions to increase value proposition to investigators.
- Facilitate preparation and collection of site level documents. Execute site initiation and training activities. Perform monitoring visits according to monitoring plan and author study monitoring reports.
- Manage site drug supply management.
- Resolve site level update of technical systems (ClinAdmin, EDC).
- Ensure site activities in line with milestones (i.e. startup, recruitment, closeout, etc).
- Manage recruitment implementing appropriate contingency plans as needed.
- Assure continual GCP, ICH and SOP compliance (Informed consent process, source data verification, AE and SAE reporting, IN, protocol, drug accountability etc.).
- Resolve deviations to standard by remedial action and training. Perform data query resolution process (both at Site and with Data Management).
- Execute site closeout activities.
- May act as local (or global) CRA Lead, as assigned. May act as a mentor to new associates for purposes of field training, as assigned.
- Industry experience necessary - no Coordinators for this role will be considered at this time.
- Basic medical and business knowledge.
- Desired competency in clinical research or having demonstrated adequate level of proficiency within the CRA II competency profile.
- Understands and can apply knowledge of clinical trial designs to trial execution.
- Knowledge and experience in international standards (GCP/ICH), international (FDA, EMEA) and local regulations.
- Expertise in communication, managing multiple priorities and computer literacy
Education A degree in a scientific or health care discipline preferred. BA/BS/BSN