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Specialist, Biorepository Operations
2 weeks ago
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.
- 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.
- 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.
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, India, Europe, and the U.S., IAVI is pioneering the development of biomedical innovations designed for broad global access. We develop vaccines and antibodies in and for the developing world and seek to accelerate their introduction in low-income countries. IAVI programs and partnerships are grounded in the regions of the world where the disease burden is the greatest, and our approach emphasizes sustainability. Our network of clinical research center partners in Africa and India helps strengthen in-country research capacity and supports the training and education of the next generation of scientists. The global impact of our science includes fundamental contributions to understanding the biology of HIV infection, which IAVI and others are applying toward advancing vaccine science and immunology. IAVI accelerates scientific discovery and development by fostering unique collaborations among academia, industry, local communities, governments, and funders to explore new and better ways to address public health threats that disproportionately affect people living in poverty. Our global reach, including a clinical research network in five countries in sub-Saharan Africa and in India, has allowed us to make fundamental contributions to understanding the epidemiology, transmission, virology, and immunology of HIV. This work played a key role in facilitating the design of promising HIV vaccine candidates, as well as the discovery of broadly neutralizing antibodies that are now being advanced as promising approaches for HIV prevention. Our integrated capabilities in vaccine and antibody discovery, development, and clinical research take advantage of bio-pharmaceutical industry expertise to accelerate the development and testing of prevention methods for HIV and other diseases. Through the Product Development Center, we support external researchers with technical and scientific expertise to accelerate the development of their own products.
IAVI CORE VALUES:
- Dedication to the Mission: We are committed to the translation of scientific discoveries into affordable, globally accessible public health solutions.
- Innovative Evolution: We are committed to solving complex problems in creative and innovative ways, learning from our mistakes and successes and never giving up
- Integrity: We are committed to meeting the highest ethical and professional standards in everything we do and to taking responsibility for our actions to earn respect
- Collaboration: We are committed to embracing diversity, the power of global teamwork and the belief that by working as one we can make a difference
IAVI IS AN EQUAL OPPORTUNITY EMPLOYER actively committed to fostering a diverse and inclusive global organization. IAVI believes that diversity and inclusion among our teammates is critical, and we seek to recruit, develop and retain the most talented people from a representative candidate pool. At IAVI, we celebrate the spectrum of colleagues' experiences and believe that dedication to our mission above all is essential to our success as a scientific global non-profit. IAVI upholds these principles through IAVI's Global Diversity and Inclusion Committee.
IAVI has zero tolerance for discrimination or harassment on the basis of race, color, ethnicity, caste, national origin, home language, ancestry, religion, marital or civil partnership status, age, physical or mental disability, HIV status and any other medical condition, genetic information, pregnancy, sexual orientation, gender identity or expression, and veteran status, in addition to any other status protected under the law in any of our locations worldwide.
Compensation and Benefits Information for US-Based Candidates:
The annual base salary for this position is targeted at$70, ,000.00
Please note, there may be some variation based on experience level. In addition, this position offers competitive benefits such as annual bonus, generous retirement savings plan, three health insurance plans to choose from, and other benefits.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR c)
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