Natera is looking for a Sr. Clinical Biospecimen Operations Associate to manage and execute biosample activities for clinical research studies, ensuring compliance with protocols, contracts, and regulatory requirements, and to maintain oversight of study operational activities from start-up to close-out.
Requirements
- Excellent project management skills, including timeline management and customer focus biospecimen management, sample processing, and biobanking best practices.
- 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.
- Demonstrated ability to work independently in a fast-paced organization.
- Demonstrated analytical skills and ability to identify problems and propose solutions.
- Detail oriented, with solid organization and time management skills.
Responsibilities
- Maintain oversight of all study operational activities including supporting routine study requirements efforts to drive readiness timelines, kick-off and planning activities, study conduct management within contractual agreements, and closure activities.
- Regularly monitors the overall health of the study from study start-up through closure, including routine evaluation of key metrics (TAT, TNP), project management of key milestones and activities, and escalation of project risks and mitigation plans both internally as well as to the study sponsor when appropriate.
- Works with Data Management and Sample Management to develop and maintain dashboards and KPIs representing metrics and trends related to clinical trial sample testing and the overall health status of clinical studies.
- Escalation of data management and sample management issues that may be impacting patient testing or reporting and that extend beyond the established procedures to appropriate internal or study sponsor stakeholders for case resolution.
- Utilize operational and project management skills to anticipate, investigate and resolve issues to ensure deliverables and TAT are met; raise issues to CTS leadership.
- Review and provide input to clinical study protocol for sample collection requirements and alignment with the SOW, study plans and company policies.
- Assist in the preparation, handling, filing, and archiving of clinical documentation and reports according to SOPs and study requirements; set up and maintain study files in eTMF (when applicable).
Other
- Demonstrated ability to facilitate meetings both internally and externally, providing meeting agendas and minutes as appropriate.
- Assist in developing study plans (e.g. Communication Plan) and departmental and study specific SOPs and work instructions with SME.
- Partner with other cross-functional groups at Natera to achieve study deliverables.
- Employee must provide records of current training or complete training relating to HIPAA/PHI privacy, human subjects protection, and GCP.
- Minimum of 2-5 years of experience working on clinical studies in the academic, biopharma, diagnostics, or medical device fields
