Daniela Moran Email & Phone Number

Washington Dc-Baltimore Area

Ensure the client complies with applicable Federal laws, National standard and institutional policies by managing the activites of the IACUC. Manage all aspects to the client's IACUC programAnalyze, coordinate and evaluate IACUC program, operational procedures, including review and evaluate the program description and associated policies and procedures related to IACUC administration and advise on modification or development of necessary, accompanying workflows processes or other resources to support compliance in the animal care and use programWork in conjunction with the IACUC chair to determine areas of risk or noncompliance with regulations and to ensure that description of planned research Manage the protocol process and the semi annual inspection and program review Ensure that approved procedures are performed as described (Post approval monitoring) Assist with on-site visits, regulatory and credit agencies, such as AAALAC

Louisville, Kentucky, United States

Develop processes and procedures for the management of non-study specific documents required for the conduct of researchDevelop and analyze monthly reports to ensure regulatory compliance with federal regulations, including IRB expiration dates, federal oncology requirements, and other quality assurance activitiesOversee the flow and preparation of research submissions to the IRB in a manner that demonstrates understanding of federal regulations governing human subjects in research (45 CFR 46, 21 CFR 50, 56, 312, 812, and HIPAA).Provide regulatory support for continuing review, amendments, and IND safety reports. This includes evaluating the protocol and sponsor documents, developing regulatory documents in compliance with the protocol and federal/local requirements, prepare IRB modifications, process requested changes and modify regulatory documents accordingly, manage documents in accordance with sponsor, IRB and federal government requirements, compile continuing review data; investigate study irregularities; Prepare studies for closure and resolve any outstanding relevant queries.Serve as liaison for shared drive development

Houston, Texas, United States

Responsible for the comprehensive review of pre-clinical research (IACUC, HSC, IBC) protocols, and associated submissions for completeness, consistency, and compliance with regulations, guidelines, and institutional policies. Coordinate all aspects of research protocol submission, review, and approval processes ensuring quick turn around times and meeting tight deadlines.In collaboration with leadership, advise and provide input to Principal Investigators and other research stakeholders on the interpretation of regulations and guidance from oversight authorities, compliance matters, and institutional processes in preparation of protocol submissions for committee consideration.Assist Committee Chairs and other team members in management of committee meetings, including providing guidance to the members on regulatory requirements, preparing the meeting agenda, completing minutes and drafting official correspondence.Create educational and training materials for research protections training, committee member education, and Open House sessions. Schedule and conduct onboarding training for new committee members.Assist in the development and implementation of cross functional processes and workflows to effectively promote congruence between safety committees. Assist in research protection (re)accreditation processes.Managed IACUC committee for a period of 6 months due to staff shortage. This included managing the daily work activities of the work unit/department staff, assisting the director to ensure operational needs/capabilities, drafting/editing standard operating procedures, facilitating the IACUC meeting and compiling the semi-annual inspection report.

San Diego, California, United States

Provide oversight of the animal care and use protocol review process for submissions, IACUC review, and investigator communications.Serve as the San Francisco regional IACUC contact for principal investigators and other research stakeholders. This includes protocol submissions, training, onboarding, scheduling inspections and assisting in the investigation and documentation of any animal welfare concerns reported. Serve as the IACUC contact for Explora’s Contract Research Organization (CRO) internal unit. This includes working closely with study directors and animal technicians to determine feasibility and compliance with regulations. Conduct initial administrative and technical screen of all protocols and use professional knowledge and judgment to assess completeness; makes determination whether the protocol is compliant with institutional, local, state, and federal regulations/guidelines/policies.Manage and participate in the semi-annual inspections and program reviews, including preparation of draft reports to the institutional official and regulatory/accreditation agencies.Coordinate IACUC meetings, prepare meeting agendas/minutes, prepare for site inspections, AAALAC inspections and drafting annual reports.Continued to consult for the company after leaving full-time employee status

San Diego, California

Primary UCSD contact for live animal purchases and procurement for campus researchCollaborate with university veterinarians and principal investigators to assure all purchases and procurement of animals are made in compliance with appropriate federal, state and local guidelinesFacilitate and ensure clear communication between campus staff and vendor representatives in order to successfully coordinate animal shipments for over 250 labs spread over 25 facilities Technical knowledge of strain nomenclature, genotypes, and immune status. Assist with assessing health and genetic monitoring data to determine facility approval, quarantine status and required diagnostic testingResponsible for reconciliation of four funding accounts each with a $200,000 limit using ConcurPrepare yearly analytical reports for internal and external agencies including IACUC, USDA, CPRA, and DFW Maintain a monthly resource calendar used to schedule and bill veterinarian technician services, equipment rentals and diagnostic testsProven knowledge of UCSD purchasing policies, basic accounting and bookkeeping principlesContinued on as a Consulant for company after leaving full-time employee status (approx. 4 months)

Greater San Diego Area

Provide administrative support for the central coordination of a large, multicenter research project involving human subjectsTrack publications, handle travel and entertainment reimbursement Completed basic training for biomedical research which covers conflicts of interest in human subject research, basic institutional review board (IRB) regulations and review process, and HIPAA privacy protections

Greater San Diego Area

Provide administrative support to a team of project managers who researched and implemented new database tools.Aid in leading introductory seminars and presentations in an effort to promote new database tools to other UCSD departmentsGain general knowledge of the grant proposal, pre-award, and post-award documentation process