University of Maryland, Baltimore
Clinical Research Specialist
University of Maryland, Baltimore, Baltimore, Maryland, United States, 21276
Clinical Research Specialist - (230001GQ)
The University of Maryland, Baltimore (UMB) Marlene & Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) has an exciting opportunity for a full-time Clinical Research Specialist for the Hematologic Malignancies research program.
This position will be patient facing and responsible for implementing clinical research protocols on behalf of the faculty/principal investigator. The Clinical Research Specialist is the primary interface, along with the faculty member for cancer patients enrolled in clinical trials and will be responsible for screening, consenting, and enrolling the patients. Once a patient is enrolled, the Clinical Research Specialist will be responsible for guiding a patient through their courses of treatment, research visits, data collection, standard of care issues and direct research support. This position works directly with the medical care team, ancillary hospital staff, the Sponsor, and data managers within the Cancer Center.
This full-time position works Monday through Friday and may require flexibility to work outside of normal working hours.Essential FunctionsPerforms as a single Specialist in a clinical setting who is responsible for providing technical expertise to research programs and projects overseeing clinical research activities. The position develops, recommends, modifies, and implements policies and procedures for clinical research, as well as develop protocol manuals and data collection instruments. This position significantly contributes to the conduct of research.Coordinates the preparation of Institutional Review Board (IRB) and Health Insurance Portability and Accountability Act (HIPPA) protocol development and ensure compliance of research operations with protocols.Manages interaction with subject participants including eligibility screening, recruitment, enrollment, ensuring informed consent is properly secured and documented, counseling, and obtaining patient medical history.Establishes and maintains database files and reports using computer applications such as Microsoft Excel/Access. Perform data checks, audits, and data cleaning.Performs clinical research activities including advanced data analysis using statistical software such as SAS, SPSS, and R; data management (collection, entry, verification); data interpretation, and ensures compliance and clinical relevance of data.Maintains communication with participants and colleagues regarding protocol specific information and research orders.Serves as liaison to other departments such as IRB or CCT, outside organizations, government agencies, and product representatives.Oversees and coordinates the day to day clinical research operations, study initiation, execution, and completion.May provide working coordination and feedback to others.Performs day-to-day operational duties such as: monitoring the budget; ensuring quality control and safety compliance; serving as liaison with IRB, submitting invoicing, develops policies, procedures, and/or methods for laboratory experimentation; and ordering supplies.Searches relevant literature, develops conclusions on research findings, writes reports, prepare and deliver presentations of relevant findings and conclusions.Provides training to less experienced researchers; assisting in developing and submitting grants, papers, abstracts, manuscripts and presenting studies.Performs other duties as assigned.QualificationsEducation:
Bachelor's degree in a scientific field of study or related to the research of the clinical setting.Experience:
Three (3) years of clinical research including two (2) years in the relevant research specialization.Other:
May consider a combination of directly related experience and education. Some schedule flexibility may be required.Knowledge, Skills, and AbilitiesAbility to understand and utilize scientific/medical terminology and research theory in both oral and written communications.Ability to perform independent projects.Ability to network with and provide information to key groups and individuals, and work as part of a team.Knowledge of human subjects research, the regulations and policies surrounding it.Prior experience with patients and patient interaction.Ability to represent the Cancer Center and its faculty in a professional manner.Ability to keep patient information confidential and possess knowledge of HIPPA regulations.The Hiring Range for this position is in the mid $60,000s to low $70,000s, commensurate with education and experience.UMB is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law or policy.
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The University of Maryland, Baltimore (UMB) Marlene & Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) has an exciting opportunity for a full-time Clinical Research Specialist for the Hematologic Malignancies research program.
This position will be patient facing and responsible for implementing clinical research protocols on behalf of the faculty/principal investigator. The Clinical Research Specialist is the primary interface, along with the faculty member for cancer patients enrolled in clinical trials and will be responsible for screening, consenting, and enrolling the patients. Once a patient is enrolled, the Clinical Research Specialist will be responsible for guiding a patient through their courses of treatment, research visits, data collection, standard of care issues and direct research support. This position works directly with the medical care team, ancillary hospital staff, the Sponsor, and data managers within the Cancer Center.
This full-time position works Monday through Friday and may require flexibility to work outside of normal working hours.Essential FunctionsPerforms as a single Specialist in a clinical setting who is responsible for providing technical expertise to research programs and projects overseeing clinical research activities. The position develops, recommends, modifies, and implements policies and procedures for clinical research, as well as develop protocol manuals and data collection instruments. This position significantly contributes to the conduct of research.Coordinates the preparation of Institutional Review Board (IRB) and Health Insurance Portability and Accountability Act (HIPPA) protocol development and ensure compliance of research operations with protocols.Manages interaction with subject participants including eligibility screening, recruitment, enrollment, ensuring informed consent is properly secured and documented, counseling, and obtaining patient medical history.Establishes and maintains database files and reports using computer applications such as Microsoft Excel/Access. Perform data checks, audits, and data cleaning.Performs clinical research activities including advanced data analysis using statistical software such as SAS, SPSS, and R; data management (collection, entry, verification); data interpretation, and ensures compliance and clinical relevance of data.Maintains communication with participants and colleagues regarding protocol specific information and research orders.Serves as liaison to other departments such as IRB or CCT, outside organizations, government agencies, and product representatives.Oversees and coordinates the day to day clinical research operations, study initiation, execution, and completion.May provide working coordination and feedback to others.Performs day-to-day operational duties such as: monitoring the budget; ensuring quality control and safety compliance; serving as liaison with IRB, submitting invoicing, develops policies, procedures, and/or methods for laboratory experimentation; and ordering supplies.Searches relevant literature, develops conclusions on research findings, writes reports, prepare and deliver presentations of relevant findings and conclusions.Provides training to less experienced researchers; assisting in developing and submitting grants, papers, abstracts, manuscripts and presenting studies.Performs other duties as assigned.QualificationsEducation:
Bachelor's degree in a scientific field of study or related to the research of the clinical setting.Experience:
Three (3) years of clinical research including two (2) years in the relevant research specialization.Other:
May consider a combination of directly related experience and education. Some schedule flexibility may be required.Knowledge, Skills, and AbilitiesAbility to understand and utilize scientific/medical terminology and research theory in both oral and written communications.Ability to perform independent projects.Ability to network with and provide information to key groups and individuals, and work as part of a team.Knowledge of human subjects research, the regulations and policies surrounding it.Prior experience with patients and patient interaction.Ability to represent the Cancer Center and its faculty in a professional manner.Ability to keep patient information confidential and possess knowledge of HIPPA regulations.The Hiring Range for this position is in the mid $60,000s to low $70,000s, commensurate with education and experience.UMB is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law or policy.
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