Biology, Chain of Custody, Clinical Medicine, Clinical Outcomes, Clinical Research, Clinical Support, Clinical Trial, Communication Skills, Corporate Policies, Data Mining, Detail Oriented, Diagnostics Solutions/Software, Disease, Documentation, Equipment Maintenance/Repair, Establish Priorities, External Audit, GCP (Good Clinical Practices), Health Plan, Internal Audit, Library and Information Science, Lift/Move 40 Pounds, Medical Diagnosis, Medical Products, Metrics, Microsoft Excel, Microsoft Office, Microsoft Outlook, Microsoft Windows Operating System, Microsoft Word, Multitasking, Operational Support, Order Supplies, Organizational Skills, Patient Care, Presentation/Verbal Skills, Problem Solving Skills, Process Improvement, Pulmonary Disease, Quality Control, Quality Management, Research Protocols, Scientific Research, Specimens/Samples, Standard Operating Procedures (SOP), Test Plan/Schedule, Test Tools, Time Management, Training/Teaching, Willing to Travel, Writing Skills
ABOUT US
Biodesix is a leading diagnostic solutions company, driven to improve clinical care and outcomes for patients. Biodesix Diagnostic Tests support clinical decisions to expedite personalized care and improve outcomes for patients with lung disease. Biodesix Development Services enable the world's leading biopharmaceutical, life sciences, and research institutions with scientific, technological, and operational capabilities that fuel the development of diagnostic tests, tools, and therapeutics.
Our Mission: Transform patient care and improve outcomes through personalized diagnostics that are timely, accessible, and address immediate clinical needs.
Our Vision: A world where patient diseases are conquered with the guidance of personalized diagnostics.
For more information, please visit www.biodesix.com.
THE ROLE:
The Sample Control Specialist will be responsible for managing all clinical and some select commercial samples, as well as ensuring the equipment is appropriately maintained. The Sample Control Specialist will be responsible for tracking the lifecycle of samples including receipt, storage, and disposition within the Sample Management System. This position will be responsible for managing the freezer storage area in Louisville, CO.
POSITION HOURS & LOCATION:
On-Site in Louisville, CO
Full-Time
WHAT YOU''LL DO:
- Manage sample handling and accessioning, storage and inventory processes and systems
- Maintains quality control and chain of custody of specimen samples
- Inventories clinical samples in collaboration with the Sample Inventory Specialist
- Maintains and orders clinical sample supplies
- Communicates sample information with stakeholders
- Supports Clinical Operations with filing and collating trial documentation and reports
- Applies knowledge of company policies and standard practices to resolve problems
- Analyzes issues and uses judgment to make decisions
- Escalates non-standard problems or issues as may be required
- Maintains open communication channels with study sites and members of the study team
- Author, edit, and upkeep of departmental standard operating procedures with management and team
- Follows Biodesix sample management policies and procedures
- Assist with internal and external audits as applicable
- May provide training and/or guidance to entry-level associates, analysts, interns, and specialists
- Other responsibilities as assigned
WHAT YOU''LL BRING:
- Experience with Windows operating system, Microsoft Office Suite, Excel skills
- Knowledge of clinical trial methodology
- Familiarity with GCP/ICH Guidelines for clinical research studies
- Ability to manage multiple aggressive timelines in a fast-paced work environment effectively
- Strong data mining and metric presenting skills
- Able to travel out-of-state
- Must be detail-oriented and possess strong organizational and time management skills with the ability to prioritize and manage completion of multiple tasks/projects, communicating when necessary with company personnel to execute
- A motivated self-starter able to perform the required responsibilities with minimal direction.
- Ability to work as part of internal and remote teams with a strong understanding and appreciation of other department/personnel's work disciplines
- Ability to physically lift up to 40 lbs. on an occasional basis and perform activities that require repetitious hand and arm movements
EDUCATION AND EXPERIENCE:
- HS Diploma required
- Bachelor's Degree preferred, in a health-related field or Library Sciences a plus
- Knowledge of Good Laboratory Practices
- Knowledge of Good Clinical Practices
- Proficient in MS Excel, MS Word, MS Outlook
COMPENSATION:
- Hourly Base salary starting at $25
- 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.