What are the responsibilities and job description for the Clinical Research Associate position at Biodesix, Inc.?
ABOUT US
Biodesix is a leading diagnostic solutions company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix offers five Medicare-covered tests for patients with lung diseases. The blood based Nodify Lung® nodule risk assessment testing strategy, consisting of the Nodify XL2® and the Nodify CDT® tests, evaluates the risk of malignancy in pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood based IQLung™ strategy for lung cancer patients integrates the GeneStrat® targeted ddPCR™ test, the GeneStrat NGS® test and the VeriStrat® test to support treatment decisions across all stages of lung cancer with results in an average of two to three business days, expediting the time to treatment. Biodesix also leverages the proprietary and advanced Diagnostic Cortex® AI (Artificial Intelligence) platform, to collaborate with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. Learn more about us at biodesix.com.
OVERVIEW
The Clinical Research Associate will work closely with the Clinical Development Team to provide support for management and conduct clinical trials and collaborations. This office-based position includes responsibilities in regulatory administration, data management, site & vendor management and project development & maintenance.
JOB LOCATION
Southeastern United States*
- This role requires regular travel to our clinical sites in the Southeastern United States including but not limited to VA, NC, SC, GA, AL, MS, TN, LA, FL
- Must reside within commutable distance to a major airport.
TRAVEL Up to 70%
RESPONSIBILITIES
- Interface with clinical sites and support site management activities.
- Assist with the preparation, conduct and follow-up of site monitoring activities and visits.
- Participate in clinical data management activities, source data verification, query reconciliation and database maintenance.
- Order, track, and manage trial materials.
- Contribute to the development and update of clinical trial support documents.
- Daily interaction with members of the cross-functional study team.
- Other duties as assigned.
REQUIREMENTS
- Knowledge of FDA regulations and ICH GCP guidelines
- Strong verbal and written communication skills
- Functional computer skills (proficient with Microsoft Office Word, Excel and Power Point)
- Ability to manage and prioritize workload effectively
- Available to travel as needed and able to manage travel schedule and reservations
- Valid driver’s license, proficient driving skills, reliable transportation and current car insurance.
EDUCATION AND EXPERIENCE
- Bachelor’s degree or equivalent combination of education/experience in science or health-related field, required
- 1-2 years of clinical research experience, required:
- At least 1 year as a Certified Clinical Research Coordinator, or
- At least 1 year as a field Clinical Research Associate in combination with Clinical Research Coordinator experience
- Oncology & Pulmonology experience, preferred
COMPENSATION
We are excited to provide
- Annual Base Salary $60,000 - $67,700
- Discretionary Bonus opportunity
- Comprehensive health coverage: Medical, Dental, and Vision
- Insurance: Short/Long Term Disability and Life Insurance
- Financial benefits: 401(k), Flex Spending Account
- 120 hours of annual vacation
- 72 hours of paid sick time off
- 11 paid holidays 3 floating holidays
- Employee Assistance Program
- Voluntary Benefits
- Employee recognition program
Individual base compensation is based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related aspects.
Biodesix is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Salary : $60,000 - $67,700
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