Clinical Scientist I (Sample Coordinator)
Full Time
Rochester, NY 14626
Posted
Job description
The Career Potential
Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That’s something we can all take pride in as we take this journey together.
Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It’s who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.
The Opportunity
As QuidelOrtho continues to grow, we are seeking a Clinical Scientist I (Sample Coordinator). The Clinical Scientist, under the supervision of the Clinical Affairs Manager will be responsible for managing the inventory of clinical samples and non-clinical samples collected and purchased by the clinical affairs group. The Clinical Scientist will work in a team environment on sample acquisition, related handling, and proper management to ensure samples are available for testing purposes. The individual will drive results through a focused and disciplined approach to clinical development that is consistent with best practices in the industry. This position is located in Rochester, NY.
The Responsibilities
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Receipt and reconciliation of incoming sample shipments.
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Management of sample inventory within the Labware database.
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Database tracks sample storage location, space allocation, demographic and/or medical information related to samples.
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Receipt and Processing requests for sample retrieval from the biorepository.
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Assisting project teams with the acquisition of characterized samples from vendors.
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Preparing samples for offsite shipping to Centers of Excellence testing sites.
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Aliquoting serum and plasma samples upon receipt from collection sites.
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Maintain EXCEL spreadsheet of patients and intended testing sites.
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Ordering and receiving materials necessary for sample collection kits
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Support clinical personnel with the assemble and shipment of collection kits to collection sites.
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Coordinate the biorepository function in support of clinical trials, handling of potentially biohazardous materials including blood, body fluids and other tissues from various sources, data management of the data associated with the specimens including support of clinical trial logistics (sample fulfillment, shipments, randomization, and labeling).
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Performs other work duties as assigned.
The Individual
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Bachelor or higher degree required in a biological science (medical technology, clinical laboratory science, microbiology, infectious diseases, immunology, biochemistry, or closely related science).
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3 or more years of clinical laboratory experience, R&D, or validation experience preferred.
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Experience with diagnostic laboratory methods and handling biohazardous materials including proficient pipetting skills.
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Must be willing to work with potentially biohazardous materials in an approved safe manner and to work in biohazardous environments.
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Knowledge of regulations and standards (CFR, GCP, ICH, ISO, etc.) affecting IVDs and Biologics required.
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Demonstrated ability to build and foster relationships with scientific and medical thought leaders.
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Must be able to work both independently and within a cross-functional team environment.
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Proven oral and written communication skills.
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Proven interpersonal, leadership and organizational skills & effective time management.
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Ability to work independently and within a cross-functional team environment to solve problems and to make sound decisions.
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Strong interpersonal and negotiating skills when dealing with colleagues, peers, and outside professional contacts.
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Demonstrated experience in computer skills to include Microsoft Word, Excel, and basic templates.
Key Working Relationships
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Internal: Interacts with department personnel from, Clinical Affair Team Leads and Assay Product Development to align deliverables required for the conduct of clinical studies.
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External: Interacts with clinical investigators, consultants, sample vendors, clinical research organizations and other external service providers to coordinate clinical sample shipments for the conduct of clinical and non-clinical studies.
EOE/AA Disability/Veteran
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