Sr. Clinical Biospecimens 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 and Sample Management to develop dashboards.
• 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 assist in developing study plans.
• Assist in preparation and archiving of clinical documentation.
• Monitor studies for protocol deviations or data discrepancies.
• Partner with 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.
• Pass post-offer criminal background check.
• 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 organization.
• Demonstrated analytical skills and problem-solving abilities.
• Detail-oriented with solid organization skills.

Benefits

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