The Clinical Research Specialist serves as a regulatory expert and resource for investigators and others within the Clinical Research Support Office in the Hospital.
The Clinical Research Specialist conducts internal for-cause/not-for-cause and new investigator audits, tracks deviations for early intervention, and supports clinical trial registration in Good Clinical Practice (GCP) and reporting. Maintains SOPS, supports GCP workgroups, newsletter, and online Investigator Manual. Will identify process and practice opportunities for performance improvement. They will participate in research and scholarly activities to advance the science of regulatory support.
Bachelor's degree or higher required; educational emphasis in psychology, healthcare, communications or statistics, and CCRA certification preferred or attained within the first year of hire. Must have a minimum of three years of experience in clinical research conduct. Experience in audit/monitoring, GCP, documentation, IND/IDE applications, or other compliance filings is a plus. Must be organized, punctual, detail and deadline-oriented. Must work well with investigators, team members, and supervisors. Must possess excellent oral/written communication skills. Spanish knowledge is a plus but not required.
The Rockefeller University does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy, gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service or other non-merit factor. All qualified applicants will receive consideration for employment without regard to the characteristics listed above.
The salary of the finalist selected for this role will be set based on various factors, including but not limited to organizational budgets, qualifications, experience, education, licenses, specialty, and training. The hiring range provided represents The Rockefeller University's good faith and reasonable estimate of the range of possible compensation at the time of posting.