Children's National Hospital
Sr. Clinical Research Coordinator
Children's National Hospital, Washington, District of Columbia, us, 20022
The Senior Clinical Research Coordinator independently leads day-to-day operations of clinical research studies conducted by a principal investigator with limited supervision. In addition, the individual performs a variety of complex duties involved in the collection, compilation, documentation and analysis of clinical research data. The Senior Clinical Research Coordinator will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations. This individual may support multiple investigators with clinical and translational research projects and direct the work of a Clinical Research Assistant and Clinical Research Coordinator as assigned.
Minimum Education B.A./B.S. degree in a science, technical, health-related field or other applicable discipline with at least 3 years of relevant experience (Required) Or Master’s degree with at least 2 years of relevant experience (Required).
Minimum Work Experience At least 3 years of experience with a bachelor's degree (Required). Or At least 2 years of experience with a master's degree (Required).
Required Skills/Knowledge
Knowledge of clinical research designs and needed infrastructure.
Familiarity with databases, data collection tools and data analysis methods.
Ability to manage multiple complex activities while maintaining close attention to detail and not losing sight of the organizational mission.
Interpersonal skills that demonstrate formal and informal leadership in a diverse professional environment.
Required Licenses and Certifications
Internal candidates: Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA) or equivalent research certification upon hire (Required).
External candidates: Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA) or equivalent research certification within one year of hire, 1 Year (Required).
Functional Accountabilities Responsible Conduct of Research
Consistently demonstrates adherence to the standards for the responsible conduct of research.
Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator.
Stays informed of and adheres to institutional policies, and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidances (International Counsel on Harmonization) regarding human subjects’ research and use of protected health information.
Uses research funds and resources appropriately.
Maintains confidentiality of data as required.
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Minimum Education B.A./B.S. degree in a science, technical, health-related field or other applicable discipline with at least 3 years of relevant experience (Required) Or Master’s degree with at least 2 years of relevant experience (Required).
Minimum Work Experience At least 3 years of experience with a bachelor's degree (Required). Or At least 2 years of experience with a master's degree (Required).
Required Skills/Knowledge
Knowledge of clinical research designs and needed infrastructure.
Familiarity with databases, data collection tools and data analysis methods.
Ability to manage multiple complex activities while maintaining close attention to detail and not losing sight of the organizational mission.
Interpersonal skills that demonstrate formal and informal leadership in a diverse professional environment.
Required Licenses and Certifications
Internal candidates: Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA) or equivalent research certification upon hire (Required).
External candidates: Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA) or equivalent research certification within one year of hire, 1 Year (Required).
Functional Accountabilities Responsible Conduct of Research
Consistently demonstrates adherence to the standards for the responsible conduct of research.
Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator.
Stays informed of and adheres to institutional policies, and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidances (International Counsel on Harmonization) regarding human subjects’ research and use of protected health information.
Uses research funds and resources appropriately.
Maintains confidentiality of data as required.
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