The company is looking to solve the problem of efficiently managing clinical trial samples and data in oncology research studies.
Requirements
- Familiarity with biospecimen management, sample processing, and biobanking best practices
- Experience with clinical EDC systems
- Familiarity with the organization and structure of the Trial Master File (TMF)
- Competency in SOPs, ICH-GCP, FDA Regulations
- Proficiency in MS Word, Excel and PowerPoint
- Experience with electronic Trial Master File (eTMF)
Responsibilities
- Maintain oversight of all study sample operational activities
- Work with Data Management to develop and maintain dashboards and KPIs
- Meticulously track clinical trial samples from sample receipt to result reporting
- Utilize operational and project management skills to anticipate, investigate and resolve issues
- Review and provide input to clinical study protocol for sample collection requirements
- Oversee clinical trial supplies related to biospecimen collection, processing, shipment, and storage
- Monitor studies to identify protocol deviations or data discrepancies
Other
- BA/BS degree in life sciences, related field, or equivalent
- Minimum of 5 years of experience working on clinical studies
- Demonstrated ability to work independently
- Outgoing and confident demeanor
- Demonstrated analytical skills and ability to identify problems and propose solutions
- Detail oriented, with solid organization and time management skills
- Must maintain a current status on Natera training requirement including General Policies and Procedure Compliance and security training
- Must pass post offer criminal background check
- Must provide records of current training or complete training relating to HIPAA/PHI privacy, human subject’s protection, and GCP
