Responsible for the timely collection, transport and shipping of biospecimens obtained from subjects enrolled in research protocols. Maintains records associated with the collection and shipment of biospecimens and packages shipments as required by protocol. Monitors clinic and other schedules to ensure subjects are scheduled for protocol required visits and/or procedures. Obtains informed consent from subjects who are participating in non-treatment clinical trials that only capture biospecimens and data.
- Works under the supervision of the Clinical Trials Administrator, Investigators, Disease Team Chair and the direction of the Clinical Research Nurse Manager.
- Performs protocol specific duties required per the research protocol, including but not limited to:
- Confirms the presence of a signed informed consent from a subject prior to specimen collection.
- Monitors clinic and other schedules to ensure subjects have been scheduled for upcoming protocol procedures which require research specimen collection.
- Assembles lab kits and other supplies in preparation to obtain required biospecimen samples and transports to appropriate laboratories for processing; ships samples externally according to International Air Transport Association (IATA) requirements.
- Manages and orders all supplies required to obtain biospecimens.
- Regularly performs an inventory to identify and discard expired collection tubes, etc.
- Attends site initiation visits.
- May obtain informed consent from specimen collection only studies, if approved by the IRB.
- Abstracts data from the medical record and completes paper and electronic forms, including responding to any requests for data clarification, and maintains all necessary source documents.
- Responds to data queries as appropriate.
- Identifies and communicates important protocol and data management issues or problems to the research team and supervisor in a timely manner.
- Maintains all required documentation for review by sponsors and others.
- Upon study closure, provides all specimen collection and shipping records to the research team for archival.
- Provides staff relief as required to meet the needs of the department.
- Flexes schedule to meet the needs of the department.
- Works collaboratively and communicates regularly with all members of the study team.
- Participates in scheduled team/department meetings.
- Participates in quality improvement projects on an on-going basis including the development of policies and procedures and standard operating procedures to improve day-to-day efficiency
Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.
Performs other related duties as assigned or requested.
Minimum Education and Skills Required for Consideration:
- Bachelor’s degree, preferably in biomedical or biological sciences.
- Knowledge of medical terminology.
- Exposure to clinical trials or related health field.
About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 4000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy. Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation’s 20 leading cancer centers that develops and institutes standards of care for cancer treatment.
City of Hope is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color national origin, sex, age, status as a protected veteran, or status as a qualified individual with disability.
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