Specialist, Biorepository Operations

As an organization whose mission is to translate science into global public health impact, working on vaccines and therapeutics, IAVI has a vaccine policy which states that subject to applicable law, we require all U.S. and Puerto Rico based employees to be vaccinated for COVID-19, unless they have an approved medical or religious exemption or accommodation. We are committed to supporting our employees during this process as we work to ensure a safe and healthy work environment.

Position Description

Job Title:             Specialist, Biorepository Operations
Location:            New York, NY preferred; US-remote considered
Reports to:         Director, Clinical Biorepository Operations

Position Summary:

Are you a Biorepository Lab professional, seeking a dynamic role in a mission-driven organization? 

IAVI is seeking a Specialist, Biorepository Operations to support biorepository and clinical lab program activity for IAVI sponsored clinical trials in the US and Europe.  The Specialist will support and execute various activities including conducting document review, sourcing study supplies, archiving relevant study materials, files, and correspondence. The Specialist will schedule and coordinate biospecimen shipments from sites, sharing packaging and labelling procedures to ensure adherence to regulatory compliance, including international regulatory governing shipment of human tissues for research. The Specialist will liaise with trial site lab teams, ensuring sample shipments are conducted with the highest standard and within planned timelines.

If you’re a biorepository lab professional who’s eager to make an impact on public health, learn more and apply below!

Key Responsibilities:

• Collaborate with the Director, Clinical Biorepository Operations to maintain accurate specimen inventory in the Biological Specimen Inventory (BSI) database for all incoming and outgoing specimen shipments.
• Coordinate data reconciliation of clinical trial samples and resolve identified discrepancies with the sites.
• Perform routine data entry in the BSI for incoming and outgoing biological samples, maintaining documentation and ensuring all shipping documentation fulfills generally accepted professional/industry standards.
• Perform review of Clinical Laboratory documents as needed before filing or submission for approval.
• Review specimen collection tables for study protocols.
• Utilize applicable computer programs during inventory transactions and routine tasks (i.e., BSI, Word, Excel, Laboratory Information Management Systems (LIMS), etc.)
• Maintain good relations with IAVI collaborators/partners, investigators, and trial site staff to facilitate efficient and high-quality execution of clinical trials and studies.
• Assist with procurement of clinical trial supplies for sites as needed.
• Keep the Director, Clinical Biorepository Operations informed of day-to-day progress of assigned tasks.
• Address sample queries and requests for clarification.
• Other duties as assigned by the Director.

Education and Experience:

• Bachelor’s degree in biology or related field is required.
• Minimum of two years of experience in biorepository operations within a Clinical Research Organization (CRO), Central Laboratory, pharmaceutical, biotech or academic setting is required.
• Experience working in Laboratory Information Management Systems (LIMS), Biological Specimen Inventory (BSI) system experience is preferred.
• Experience in data entry, sample management, sample handling and biorepository services is required.

Qualifications and Skills:

• Proficient in Laboratory Information Management Systems (LIMS), Biological Specimen Inventory (BSI) system experience is preferred.
• Documented training in IATA and DOT regulations.
• Good knowledge of GCLP, GCP or GxP guidelines.
• Demonstrated organizational skills and ability to meet timelines.
• Willing to travel as needed.
• Ability to work alone and in a team as part of an active research department.
• Energy and enthusiasm for the IAVI mission and working across multiple countries.
• Ability to effectively train others on sample management topics.
• Flexible, patient, diplomatic, and a problem solver.

Organizational Overview:

IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. Our mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Through scientific and clinical research in Africa, I