Sr. Clinical Biospecimen Operations Associate - Remote

Overview

The Sr. Clinical Biospecimen Operations Associate is responsible for the execution of biosample activities for clinical research studies utilizing Natera tests, including leading coordination of operational activities for project execution, conduct, and close-out in scope with the study contracts, as applicable, and clinical study protocols.

In Short

• Maintain oversight of all study operational activities.
• Regularly monitor the overall health of the study.
• Work with Data Management to develop dashboards and KPIs.
• Escalate data management and sample management issues.
• Utilize operational and project management skills to resolve issues.
• Review and provide input to clinical study protocols.
• Facilitate meetings and develop study plans.
• Assist in the preparation and archiving of clinical documentation.
• Monitor studies for protocol deviations.
• Partner with other cross-functional groups to achieve study deliverables.

Requirements

• BA/BS degree in life sciences or related field.
• 2-5 years of experience in clinical studies.
• Excellent project management skills.
• Familiarity with Trial Master File (TMF).
• Competency in SOPs, ICH-GCP, FDA Regulations.
• Proficiency in MS Word, Excel, and PowerPoint.
• Ability to work independently in a fast-paced environment.
• Detail oriented with solid organization skills.
• Demonstrated analytical skills.
• Outgoing and confident demeanor.

Benefits

• Comprehensive medical, dental, and vision plans.
• Free testing for employees and their families.
• 401k benefits.
• Generous employee referral program.
• Pregnancy and baby bonding leave.