The Lead Clinical Research Coordinator independently leads and oversees day-to-day operations of clinical research studies conducted by a principal investigator with minimal supervision. This individual 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. The Lead Clinical Research Coordinator may directly supervise a limited number of Clinical Research Coordinators or other research staff.
Qualifications:
Minimum Education
Bachelor's Degree B.A./B.S. degree in a science, technical, health-related field or other applicable discipline with at least 5 years of relevant research experience. (Required) Or
Master's Degree Master's degree with at least 4 years of relevant research experience. (Required) Or
Doctor of Philosophy (Ph.D.) Doctoral degree with at least 2 years of relevant research experience. (Required)
Minimum Work Experience
5 years At least five years of experience with a bachelor's degree. (Required) Or
4 years At least four years of experience with a master's degree. (Required) Or
2 years At least 2 years of relevant research experience with a doctoral 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), Certified Clinical Research Associate through the Association of Clinical Research Professionals (ACRP) 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
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