Are you an accomplished Sr CRA with experience in Phase 1 and Phase 2 clinical trials with a therapeutic focus in Oncology? Apply now to join our awesome team!
Translational Drug Development (TD2) is a world-class drug development CRO, specializing in getting the newest and best oncology treatments to cancer patients as quickly as possible.
CRA locations preferred:
- Eastern USA - New York/New Jersey/Pennsylvania area
- Western USA - Nevada, Utah, Arizona area
- Midwest/Southern USA - Minnesota to Texas area
We are looking for CRAs with the following specialized/technical skills:
- Minimum of five years of work as a CRA in a CRO or pharmaceutical environment
- Minimum of five years of experience monitoring Phase I clinical trials
- Minimum of four years of experience in the therapeutic field of oncology
- Field-based with ability for 75% overnight travel
- Strong knowledge of GCP, ICH, and FDA regulatory requirements
- Excellent presentation skills
- Strong computer skills in Microsoft Office tools, Site EMR, EDC, and CTMS systems
Perform CRA duties (including, but not limited to):
- Monitor all aspects of assigned Phase 1 and 2 oncology clinical trials to ensure the protection and welfare of subjects, compliance with the protocol, GCP/ICH guidelines, FDA regulations and overall clinical objectives.
- Manage clinical start-up activities, supply preparation, enrollment, data collection, and close-out.
- Organize and perform site qualification, site initiation, interim monitoring and site close-out visits according to TD2 policies and procedures.
- Write and review the clinical trial Monitoring Plan.
- Interface with clinical investigators and site staff routinely for timely resolution of issues and to assure proper trial oversite is occurring.
- Write Site Visit Reports after each visit within the allotted timeframe along with preparing Confirmation and Follow-up Letters.
TD2 is located in Scottsdale, AZ, however this position is field-based. Corporate visa sponsorship is not offered.
Job Type: Full-time
Job Type: Full-time
Salary: $100,000.00 to $110,000.00 /year
- oncology therapeutic: 4 years (Preferred)
- Phase 1 clinical trial monitoring: 5 years (Preferred)
- Do you have a minimum of 5 years of work as a CRA in a CRO or pharmaceutical environment?
- Health insurance
- Dental insurance
- Vision insurance
- Retirement plan
- Paid time off