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Employer: National Institutes of Health – Division of Cancer Epidemiology and Genetics
Biospecimen Coordinator, Connect for Cancer Prevention Study (Contractor)The National Cancer Institute Division of Cancer Epidemiology and Genetics (DCEG) is recruiting a Coordinator of Biospecimen Operations to coordinate collection, shipment, processing, storage, and future use of biospecimens. This opening is a contract position located in Rockville, MD (currently, work from home). Specifically, the Coordinator will manage the study biospecimen lifecycle for a large, prospective, epidemiologic cohort, the Connect for Cancer Prevention Study. Connect is a multi-site study based in integrated health care systems across the United States (currently, nine (9) partner locations). Biospecimens (e.g., blood, urine, saliva, tissue) will be collected from participants at recruitment and during follow-up. DCEG plans to begin recruitment in 2021. The position is responsible for: · Planning, coordinating and overseeing all planning activities required to manage the lifecycle of biospecimen samples (collection, processing, analysis, data delivery and cleaning process, and final sample disposition).· Writing and reviewing of laboratory Standard Operating Procedures (SOPs), laboratory manuals, and training manuals in conjunction with staff from the health care systems, internal NCI investigators, and the NCI Central Laboratory.· Leading protocol development, including study related documents, regulatory issues/concerns, and audits, with staff from the health care systems, internal NCI investigators, and the NCI Central Laboratory.· Supporting the implementation of IT capabilities to enhance operational effectiveness, biospecimen tracking, and operational data tracking/mining. Ensures all IT requirements are documented in alignment with the protocol and workflows.· Training and monitoring of biospecimen collection processes with an emphasis on sampling handling and packaging as well as related data capture at recruitment sites, including domestic travel to the health care systems locations yearly.· Maintaining and coordinating communication among relevant internal and external stakeholders and the NCI Central Laboratory.· Ensuring biospecimen study activities uphold the ethical conduct of research studies, as well as compliance with GCPs, federal regulations, and partner policies and procedures. · Reviewing and evaluating biospecimen collection metrics for study activities and site performance, then offering solutions towards process improvement.· Overseeing of sample aliquoting, including development of standard aliquot plan, implementation of guidelines for use, management of queue, management of specimen use and distribution requests including generating aliquoting schemas, masking of IDs, selecting samples for QCs, and plating requirements. Qualifications: A bachelor’s degree in biomedical or science-related field is required. In addition to the education requirements, a minimum of three to five (3-5) years of progressively increasing responsibilities and experience in project management in clinical studies and/or biospecimen-related fields is required. Candidates should demonstrate excellent interpersonal, organizational, prioritization, and oral/written communication skills, particularly the ability to communicate in a cross-functional and disciplinary environment. Candidates with these desired skills will be given preferential consideration: Master’s degree; experience managing a biospecimen repository (blood, urine, and/or tissue), or working as a technician or manager responsible for day-to-day activities related to biobanking and/or biospecimen collection; experience with a LIMS (laboratory information management system), electronic data management, and workflow development; and/or formal educational training in project management (MBA or PMP).How to Apply: Individuals interested in this contract position should send a cover letter detailing qualifications and a resume via email to Dr. Mia Gaudet, Senior Scientist for the Connect Study. Learn more about DCEG and the Connect study.Applications will be accepted until the position is filled.