OpenSpecimen (Krishagni)
PRINCIPAL DUTIES AND RESPONSIBILITIES
: Recruit and enroll eligible study participants from clinics throughout the hospital and other sites. Arrange and conduct initial interviews of study subjects and evaluate criteria for inclusion/exclusion. Perform Institutional Review Board (IRB) submission process by preparing protocol applications, amendments, safety reports, adverse event reports, and other documents. Capture clinical information from record review and patient interview into study database. Manage and maintain regulatory documents for audit by FDA, as needed. Prepare and manage regulatory documents for audit by FDA, as needed. Evaluate and update medical records and maintain study database. Coordinate subject care by scheduling and arranging follow-up visits, conducting follow-up telephone calls, and communicating concerns with the study investigator. Conduct regular review of study progress and follow-up. EXPERIENCE: Background in biology, immunology, biochemistry, biostatistics, epidemiology or related pre-medicine discipline preferred, but not required. Experience in a clinical research environment or with specimen biobanking preferred. A 2-year commitment is preferred, but not required.
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: Recruit and enroll eligible study participants from clinics throughout the hospital and other sites. Arrange and conduct initial interviews of study subjects and evaluate criteria for inclusion/exclusion. Perform Institutional Review Board (IRB) submission process by preparing protocol applications, amendments, safety reports, adverse event reports, and other documents. Capture clinical information from record review and patient interview into study database. Manage and maintain regulatory documents for audit by FDA, as needed. Prepare and manage regulatory documents for audit by FDA, as needed. Evaluate and update medical records and maintain study database. Coordinate subject care by scheduling and arranging follow-up visits, conducting follow-up telephone calls, and communicating concerns with the study investigator. Conduct regular review of study progress and follow-up. EXPERIENCE: Background in biology, immunology, biochemistry, biostatistics, epidemiology or related pre-medicine discipline preferred, but not required. Experience in a clinical research environment or with specimen biobanking preferred. A 2-year commitment is preferred, but not required.
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