Specimen Manager🔍School of Medicine, Stanford, California, United StatesNew📁Research📅2 days ago Post Date📅105407 Requisition #The Stanford Prevention Research Center (SPRC) within the Department of Medicine, founded in 1972, focuses on groundbreaking research to identify and modify the factors that lead to chronic conditions and diseases, including obesity, diabetes, hypertension, cardiovascular disease, cancer, mental health and aging. SPRC has a collection of renowned experts who are world leaders in investigating ways to prevent disease and promote health.The Hsing Lab at SPRC, led by PI Dr. Ann Hsing, focuses on cancer epidemiology and prevention, Asian American health, and well-being research. The Hsing Lab is seeking an exceptional, highly motivated, well-organized, and team-oriented full-time Specimen Manager with extensive experience and knowledge of epidemiological studies, including specimen collection and management, to provide leadership for several large ongoing studies at the Hsing Lab. The Specimen Manager will be responsible for leading and supervising biospecimen collection at multiple domestic and international clinics/sites; monitoring biospecimen-related activities; tracking processing of collected samples at the laboratory; coordinating the shipment of samples to Stanford CTRU for processing, coordinating with Stanford Biobank to receive biospecimens from international and domestic study sites, preparing iLab requests for the retrieval of samples at the Stanford Biobank to ship to the sponsor or outside lab for processing; and maintaining the inventory of study samples located at the Biobank and other secure storage facilities. The successful candidate will lead the research team to ensure that specimen collection goals are accomplished within allotted timelines and budgets, and that biospecimen-related activities comply with study policies and procedures. The Specimen Manager will serve as a primary liaison between the study team and Stanford Clinics, Stanford Clinical Translational Research Unit (CTRU) Clinic and Laboratory, Stanford Biobank, sponsor, data coordinating center, and study sites on biospecimen issues, and will provide guidance on workflows and processes for collecting, transporting, processing, storing, and retrieving biospecimens.If you believe that this opportunity is a match for your knowledge, skills, and abilities and you love challenging and exciting work in a nurturing and collaborative environment, we encourage you to apply. The Specimen Manager will work under the supervision of a Senior Project Manager. This is a 100% FTE hybrid position. The Specimen Manager is expected to work 2-3 days on-site each week at the SPRC office at Stanford Research Park in Palo Alto, CA.
Duties include:
Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials. Monitor staffing levels and identify adequate coverage for trial workload across teams of study coordinators.Supervise the implementation of and adherence to study protocols. Educate research staff on established policies, processes, and procedures.Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions and respond to requests and questions.Assist with analysis of data and preparation of manuscripts and scientific presentations.
DESIRED QUALIFICATIONS:
Experience and knowledge of safety and regulatory requirements for specimen handling and shipmentsKnowledge of Laboratory Information Management Systems (LIMS) and biospecimen management/tracking software and systems such as iLabExperience authoring protocols, instructions, user manuals, SOPs, and other tools for trainingExperience collaborating with large biobanks and managing biorepository, including inventory, effective sample retrieval, and sample shippingExperience in laboratory assaysPrevious experience in managing epidemiologic observational studies with biospecimen collection Ability to effectively coordinate across various study sites to implement common protocol across sites to achieve high-quality specimen collection across study sitesExcellent organizational and interpersonal skillsHigh level of self-motivation and attention to detailExpertise in online data collection methods using Qualtrics and REDCapMaster's degree in a related field and five or more years of experience in clinical research, or an equivalent combination of education and relevant experienceChinese (Mandarin), Japanese, Tagalog, Vietnamese, and/or Hebrew language proficiency is a plus
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master's degree preferred.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Excellent interpersonal skills.Proficiency in Microsoft Office and database applications.Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.Knowledge of medical terminology.Demonstrated managerial experience.
CERTIFICATIONS & LICENSES:
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
PHYSICAL REQUIREMENTS*:
Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.
WORKING CONDITIONS:
Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.May require extended or unusual work hours based on research requirements and business needs.
WORKING STANDARDS:
Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu/.
The expected pay range for this position is $120,411 to $143,265 per annum.
Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.
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The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.Additional Information